2024 PDA Visual Inspection Forum

Registration Open

Eventfoyer

Welcome and Introduction

Room Ludwig-Alois

• Committee Member: Falk Klar, PhD, Parenteral Drug Association

  

  Falk Klar, PhD, Parenteral Drug Association
  

  Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.

Welcome from the Co-Chairs

Room Ludwig-Alois

• Co-Chair: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

  

  John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
  

  John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology. John holds a BS in Chemistry from Carroll College and a PhD in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and is leading the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods, and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.

• Co-Chair: Romain Veillon, PharmD, Director Vision Technology MSAT, GSK

  

  Romain Veillon, PharmD, Director Vision Technology MSAT, GSK
  

  Romain Veillon is Director of Vision Technology at GSK, in Global MSAT Device and Aspetic Technologies. As a global expert, he is leading the Visual Inspection and leak detection performance and expertise network on multiple sites. Romain is leading a global team to manufacture and supply defect kits and; trend defects across GSK sites. He focuses on Quality Integration, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement, and Develop Equipment strategy within the network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing on Digitalization and innovation management with new AVI-LT asset deployment. Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment. Last past 25 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly, and GSK, in support of production and secondary operations projects for filling and freeze-drying. He also developed innovative vision systems with some academic collaborations and regular presentations at PDA conferences. In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain has been Interest Group Leader for Visual Inspection in PDA Europe and co-chairing the US and Europe PDA VI Forum. In 2020 Romain received the PDA James P. Agalloco Award for educational training.

Opening Plenary: Particles: A Pharmacy and Regulatory Perspective

Room Ludwig-Alois

• Moderator: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

  

  John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
  

  John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology. John holds a BS in Chemistry from Carroll College and a PhD in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and is leading the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods, and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.

• 09:15 – 09:45

  Visible, Subvisible, and Microparticles in Parenteral Drugs – Facts and Figures in Daily Clinical Practice

  • Academic Presenter: Irene Kraemer, PhD, Director Department of Pharmacy, University Medical Center, Johannes Gutenberg-University Mainz

    

    Irene Kraemer, PhD, Director Department of Pharmacy, University Medical Center, Johannes Gutenberg-University Mainz
    

    Irene Krämer, PharmD, PhD, is Director of the Pharmacy Department of the University Medical Center at the Johannes Gutenberg-University Mainz (Germany) and Professor of Clinical Pharmacy at the faculty of pharmacy at the same university. She obtained her doctorate in pharmaceutical chemistry and continued her postgraduate education at the Pharmacy Department of the Johannes Gutenberg University and went on to complete her postdoctoral thesis in Pharmaceutical Technology, entitled 'Development, Quality Assurance, and Optimization of Ready-to-Use Parenteral Solutions in the Integrated Cancer Care Concept'. The research projects of Prof. Kraemer focus on experimental studies of the physicochemical and microbiological stability of ready-to-administer parenteral preparations mainly used in oncology and intensive care patients. Other research projects deal with the development and evaluation of clinical pharmacy services and the improvement of medication safety by digitalization and automation of the medication process. She also performed numerous studies regarding medication adherence in special patient groups. Prof. Krämer published numerous scientific papers and is the author/editor of several clinical pharmacy and pharmaceutical technology textbooks. She received the German Federal Cross of Merit for her dedication to clinical pharmacy and patient care.

• 09:45 – 10:15

  From Blur to Clarity: Definition of Particle Visibility Threshold in Parenteral Drug Products

  • Co-Presenter: Felix Nikels, Senior Principal Scientist, Boehringer Ingelheim

    

    Felix Nikels, Senior Principal Scientist, Boehringer Ingelheim
    

    Felix Nikels, Boehringer Ingelheim, Senior Principal Scientist in Analytical Development Pharmacist by training with an academic research background in biochemical pharmacology and functional drug characterization. Moving back to the industry in 2016 in the field of drug product analytics. As an expert in aggregate formation, particle analytics and control strategies currently support a broad range of therapeutic modalities, from therapeutic proteins and peptides over small molecules to virus-based therapeutics and gene therapies Member (including leadership roles) of several industry consortia and scientific working groups, e.g., under the umbrella of EFPIA, IQ, AAPS

  • Co-Presenter: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

    

    Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
    

    Atanas Koulov has more than 15 years of experience in pharmaceutical drug product development from Roche/Genentech, Novartis, and Lonza, where he has held positions with increasing responsibilities up to Senior Director leading a Drug Product Analytical Development & QC organization. Atanas is a co-founder and CSO at Clear Solutions Laboratories, a service organization helping Pharma and Biotech partners tackle challenges related to particle control. His focus areas are DP control strategies, particle contamination and control, forensic chemistry, analytical development, and quality control. He has authored more than 50 scientific publications and book chapters.

• 10:15 – 10:45

  Control of Visible Particulates in Injectable Pharmaceutical Products: A Life-Cycle Approach

  • Regulatory Presenter: Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA

    

    Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA
    

    Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined the FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II, where he conducts FDA policies and program development activities related to pharmaceutical quality. Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker at multiple conferences in the area of visible and subvisible particulate testing in the past few years. He has published in peer-reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also served as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.

• 10:45 – 11:15

  Q&A, Discussion

  • Moderator: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    

    John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    

    John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology. John holds a BS in Chemistry from Carroll College and a PhD in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and is leading the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods, and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.

  • Panelist: Irene Kraemer, PhD, Director Department of Pharmacy, University Medical Center, Johannes Gutenberg-University Mainz

    

    Irene Kraemer, PhD, Director Department of Pharmacy, University Medical Center, Johannes Gutenberg-University Mainz
    

    Irene Krämer, PharmD, PhD, is Director of the Pharmacy Department of the University Medical Center at the Johannes Gutenberg-University Mainz (Germany) and Professor of Clinical Pharmacy at the faculty of pharmacy at the same university. She obtained her doctorate in pharmaceutical chemistry and continued her postgraduate education at the Pharmacy Department of the Johannes Gutenberg University and went on to complete her postdoctoral thesis in Pharmaceutical Technology, entitled 'Development, Quality Assurance, and Optimization of Ready-to-Use Parenteral Solutions in the Integrated Cancer Care Concept'. The research projects of Prof. Kraemer focus on experimental studies of the physicochemical and microbiological stability of ready-to-administer parenteral preparations mainly used in oncology and intensive care patients. Other research projects deal with the development and evaluation of clinical pharmacy services and the improvement of medication safety by digitalization and automation of the medication process. She also performed numerous studies regarding medication adherence in special patient groups. Prof. Krämer published numerous scientific papers and is the author/editor of several clinical pharmacy and pharmaceutical technology textbooks. She received the German Federal Cross of Merit for her dedication to clinical pharmacy and patient care.

  • Panelist: Felix Nikels, Senior Principal Scientist, Boehringer Ingelheim

    

    Felix Nikels, Senior Principal Scientist, Boehringer Ingelheim
    

    Felix Nikels, Boehringer Ingelheim, Senior Principal Scientist in Analytical Development Pharmacist by training with an academic research background in biochemical pharmacology and functional drug characterization. Moving back to the industry in 2016 in the field of drug product analytics. As an expert in aggregate formation, particle analytics and control strategies currently support a broad range of therapeutic modalities, from therapeutic proteins and peptides over small molecules to virus-based therapeutics and gene therapies Member (including leadership roles) of several industry consortia and scientific working groups, e.g., under the umbrella of EFPIA, IQ, AAPS

  • Panelist: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG

    

    Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
    

    Atanas Koulov has more than 15 years of experience in pharmaceutical drug product development from Roche/Genentech, Novartis, and Lonza, where he has held positions with increasing responsibilities up to Senior Director leading a Drug Product Analytical Development & QC organization. Atanas is a co-founder and CSO at Clear Solutions Laboratories, a service organization helping Pharma and Biotech partners tackle challenges related to particle control. His focus areas are DP control strategies, particle contamination and control, forensic chemistry, analytical development, and quality control. He has authored more than 50 scientific publications and book chapters.

  • Regulatory Panelist: Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA

    

    Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA
    

    Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined the FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II, where he conducts FDA policies and program development activities related to pharmaceutical quality. Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker at multiple conferences in the area of visible and subvisible particulate testing in the past few years. He has published in peer-reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also served as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.

Networking Coffee Break, Poster Session & Exhibition

Eventfoyer

Session 1: Particle Identification and Life Cycle Case Studies

Room Ludwig-Alois

• Moderator: Markus Lankers, PhD, Managing Director, MIBIC GmbH & Co KG

  

  Markus Lankers, PhD, Managing Director, MIBIC GmbH & Co KG
  

  Markus is one of the co-founders of MIBIC GmbH a company that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Before this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany. Markus holds a diploma. in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003 he helped to establish the Visual Inspection of Parenterals Interest Group in Europe as European interest group leader. He served as program co-chair for the PDA Visual Inspection Forum of Partenterals 2001-2018 in Europe and the USA.

• 11:45 – 12:00

  Company-Wide Particle Life Cycle Management - A Success Story

  • Presenter: Antonio Burazer, Global Head of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

    

    Antonio Burazer, Global Head of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG
    

    Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over responsibility for visual inspection and particle life cycle management globally for Takeda. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal of achieving zero particles in parenteral products.

• 12:00 – 12:15

  Investigation of Intrinsic Particulates in Sterile Solution: Case Study on Process vs Product Root Cause

  • Presenter: Valerie Pritiskutch, Lead Inspection Operator and Technologist, GSK

    

    Valerie Pritiskutch, Lead Inspection Operator and Technologist, GSK
    

    Valerie Pritiskutch has worked in the pharmaceutical industry for over 12 years. Currently working at GSK as a lead visual inspection operator, she worked her way up from learning the basics of packaging at ALMAC clinical supplies. She was able to receive her associate degree and looks to further her education. Valerie is on the Visual Inspection Community of Practice board at GSK. As a lead qualified operator, she must implement the best practices for new drugs, whether it is changing batch record steps or a new inspection procedure, Valerie will be involved.

• 12:15 – 12:30

  Identify Me – Particle Analysis at a Site Level

  • Presenter: Emily Beattie, Quality Technical Consultant- Global Quality Operations and Strategy, Baxter Healthcare

    

    Emily Beattie, Quality Technical Consultant- Global Quality Operations and Strategy, Baxter Healthcare
    

    Emily Beattie is a graduate of Appalachian State University and has been with Baxter Healthcare for over 9 years in various roles including Microbiology and Quality Assurance. She is a member of the Global Quality Operations Team, with expertise in Visual Inspection and Particle Analysis. Before joining the Global team, Emily worked extensively with visual inspection and particle identification at one of Baxter’s largest solution manufacturing sites. She now owns the Baxter Global Visual Inspection and Particle Analysis programs, supporting over 60 sites worldwide.

• 12:30 – 13:05

  Q&A, Discussion

  • Moderator: Markus Lankers, PhD, Managing Director, MIBIC GmbH & Co KG

    

    Markus Lankers, PhD, Managing Director, MIBIC GmbH & Co KG
    

    Markus is one of the co-founders of MIBIC GmbH a company that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Before this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany. Markus holds a diploma. in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003 he helped to establish the Visual Inspection of Parenterals Interest Group in Europe as European interest group leader. He served as program co-chair for the PDA Visual Inspection Forum of Partenterals 2001-2018 in Europe and the USA.

  • Panelist: Emily Beattie, Quality Technical Consultant- Global Quality Operations and Strategy, Baxter Healthcare

    

    Emily Beattie, Quality Technical Consultant- Global Quality Operations and Strategy, Baxter Healthcare
    

    Emily Beattie is a graduate of Appalachian State University and has been with Baxter Healthcare for over 9 years in various roles including Microbiology and Quality Assurance. She is a member of the Global Quality Operations Team, with expertise in Visual Inspection and Particle Analysis. Before joining the Global team, Emily worked extensively with visual inspection and particle identification at one of Baxter’s largest solution manufacturing sites. She now owns the Baxter Global Visual Inspection and Particle Analysis programs, supporting over 60 sites worldwide.

  • Panelist: Antonio Burazer, Global Head of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

    

    Antonio Burazer, Global Head of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG
    

    Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over responsibility for visual inspection and particle life cycle management globally for Takeda. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal of achieving zero particles in parenteral products.

  • Panelist: Valerie Pritiskutch, Lead Inspection Operator and Technologist, GSK

    

    Valerie Pritiskutch, Lead Inspection Operator and Technologist, GSK
    

    Valerie Pritiskutch has worked in the pharmaceutical industry for over 12 years. Currently working at GSK as a lead visual inspection operator, she worked her way up from learning the basics of packaging at ALMAC clinical supplies. She was able to receive her associate degree and looks to further her education. Valerie is on the Visual Inspection Community of Practice board at GSK. As a lead qualified operator, she must implement the best practices for new drugs, whether it is changing batch record steps or a new inspection procedure, Valerie will be involved.

Networking Lunch Break, Poster Session & Exhibition

Eventfoyer

Guided Poster Walk

Eventfoyer

• Moderator: Romain Veillon, PharmD, Director Vision Technology MSAT, GSK

  

  Romain Veillon, PharmD, Director Vision Technology MSAT, GSK
  

  Romain Veillon is Director of Vision Technology at GSK, in Global MSAT Device and Aspetic Technologies. As a global expert, he is leading the Visual Inspection and leak detection performance and expertise network on multiple sites. Romain is leading a global team to manufacture and supply defect kits and; trend defects across GSK sites. He focuses on Quality Integration, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement, and Develop Equipment strategy within the network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing on Digitalization and innovation management with new AVI-LT asset deployment. Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment. Last past 25 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly, and GSK, in support of production and secondary operations projects for filling and freeze-drying. He also developed innovative vision systems with some academic collaborations and regular presentations at PDA conferences. In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain has been Interest Group Leader for Visual Inspection in PDA Europe and co-chairing the US and Europe PDA VI Forum. In 2020 Romain received the PDA James P. Agalloco Award for educational training.

• 13:50 – 14:20

  Detection of defects in externally coated glass vials with automated visual inspection

  • Poster Presenter: Nico Spribille, Commercial Director Europe, Corning Inc.

    

    Nico Spribille, Commercial Director Europe, Corning Inc.
    

    Nico Spribille is responsible for market development in Europe at Corning Pharmaceutical Technologies. Nico has been working in various commercial roles in the field of primary packaging materials made of tubular glass for 16 years and has built profound knowledge of the pharma market and primary packaging madfe of glass. Nico holds a diploma in business administration from the University of Bayreuth, Germany.

• 13:50 – 14:20

  Enhanced Test Methods for Visible Particle Detection & Enumeration on Elastomeric Closures and Glass Containers

  • Poster Presenter: Jahanvi Miller, MBA, Director of Quality, Amgen Inc.

    

    Jahanvi Miller, MBA, Director of Quality, Amgen Inc.
    

    As a Director of Quality for Amgen, Jahanvi oversees all of the Americas (North, Central & South; along with Canada), she helps to develop and shape global policy/regulations that are consistent with Amgen’s positions and priorities and shares GxP intelligence throughout the organization. She also engages with internal stakeholders to meet and implement global regulatory expectations throughout the product life cycle (incl. early-warning signals). Jahanvi comes to GQC (Global Quality Compliance) with over 20 years of industry experience from PDA (Parenteral Drug Association) where she was responsible for all regulatory activities and initiatives globally of the Science Advisory Board. She worked collaboratively with PDA members and governing bodies to facilitate the production of PDA Responses to Draft Regulatory Guidance Documents, Technical Reports, Points to Consider Guidance, Training Courses, and Strategic Plans. Before joining PDA in 2012, Jahanvi worked as a clinical manager for Otsuka, an account director at OneWorld, and a research scientist at Johnson & Johnson. Jahanvi holds a Bachelor of Science Degree in Biomedical Sciences and a Master’s Degree in Business Management.

• 13:50 – 14:20

  Identify & Eliminate Sources of Visible Particles

  • Poster Presenter: Clay Foutch, Vice President of Sales, Foamtec International WCC

    

    Clay Foutch, Vice President of Sales, Foamtec International WCC
    

    Clay Foutch is the Vice President of Sales for Foamtec International. He has twenty five years of experience in cleanroom manufacturing and contamination control. First, as an engineer at Intel Corporation, and since 2000, in the Life Science market supporting the Pharmaceutical and Medical Device industries. Clay is responsible for carrying out Foamtec's mission to enable contamination control professionals the ability to improve particulate control in cleanrooms by solving surface and device contamination challenges. Clay will be giving a poster presentation on How To Identify and Eliminate Sources of Visible Particles at the 2024 PDA Visual Inspection Forum on April 09-10, 2024.

• 13:50 – 14:20

  Probability of Detection Study

  • Poster Presenter: Menno Sels, MA, Process & Project Engineer, eyetec

    

    Menno Sels, MA, Process & Project Engineer, eyetec
    

    I am a passionate Project Engineer/Manager with extensive experience in the pharmaceutical industry & GMP environments. My expertise lies in project management, & engineering, after-sales management, technical problem-solving, SME, and supporting/executing qualification/validation processes (DQ, FAT, SAT, IQ, OQ, PQ, and PV ). I have a proven track record for various equipment, including washing machines, sterilizers, freezers, bioreactors, environmental monitoring systems, visual inspection equipment (MVI, SAVI & AVI), ..... I thrive on delivering efficient solutions that meet stringent regulatory requirements while driving operational excellence.

• 13:50 – 14:20

  Visual Inspection Program Development for a Frozen Oncolytic Virus Drug Product: Overcoming Challenges

  • Poster Presenter: Lynn Ward, MS, Senior Engineer, Process Development, Replimune

    

    Lynn Ward, MS, Senior Engineer, Process Development, Replimune
    

    Lynn Ward has a Bachelor’s degree in Biology, a Master’s degree in Environmental Science, and serves as a Senior Engineer of Process Development at Replimune. She has 8 years of experience in diverse roles across the Pharma & Biotech industry and joined Replimune 3 years ago to support their oncolytic virus drug product process. Ms. Ward contributes to the visual inspection program and related processes, particularly those relating to manual visual inspection and particulate control since 2021. Ms. Ward has identified and implemented program improvements and become an active member of the PDA visual inspection community including the interest group and forums. Ms. Ward also contributes to investigation, aseptic processing, sterilizing-grade filter validation, filter integrity testing, and freezing of drug product.

Interactive Questionnaire Session

Room Ludwig-Alois

• Moderator: Hanns-Christian Mahler, PhD, CEO (Chief Enablement Officer), ten23 health AG

  

  Hanns-Christian Mahler, PhD, CEO (Chief Enablement Officer), ten23 health AG
  

  Prof. Hanns-Christian Mahler, Ph.D., is the Chief Enablement Officer and Board Member at ten23 health. He previously led the Drug Product Services Business Unit at Lonza AG (2015–2021) and worked in various leadership roles, such as Head of Pharmaceutical Development & Supplies at Roche (2005–2015) and Merck KGaA (2000–2005). He has extensive expertise in formulation development, process development and validation, packaging/device development and integration, sterile manufacturing, and regulatory submissions with numerous IND/IMPD and BLAs. Prof Mahler studied pharmacy at the University of Mainz, Germany, and holds a Ph.D. in toxicology from the Institute of Pharmacy, University of Mainz, and pharmacist specialization degrees in toxicology and ecology, and pharmaceutical technology. He also has qualifications in Business and Marketing (AKAD University, Germany). Prof. Mahler obtained his venia legendi from the University of Frankfurt, Germany, in 2010 and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He also serves as Editor for Pharmaceutical Research, Journal of Pharmaceutical Sciences, AAPS Open Journal, and PDA Journal of Pharmaceutical Sciences and Technology.

Session 2: Visual Inspection Challenges for Difficult to Inspect Products

Room Ludwig-Alois

• Moderator: Andrea A Sardella, PhD, Product Development Manager, Stevanato Group

  

  Andrea A Sardella, PhD, Product Development Manager, Stevanato Group
  

  Andrea holds a degree in Physics from Padua University and a Master's in Nuclear Engineering.
  
  As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE).
  
  After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools.
  
  He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines.
  
  Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

• 14:35 – 14:50

  Visual Inspection and Particle Mitigation Approaches for Autologous Cell Therapies

  • Presenter: Pascal Chalus, PhD, Associate Director, Lonza AG

    

    Pascal Chalus, PhD, Associate Director, Lonza AG
    

    Pascal is a chemist by training from the University of Haute Alsace (France). He acquired a PhD by applying near-infrared spectroscopy and innovative chemometric tools for the determination of drug content in low-dosed narcotics tablets at F. Hoffman-La Roche. Pascal worked then for 9 years in small molecule development of F. Hoffman-La Roche, implementing vibrational spectroscopies and imaging technologies in drug product development. He then focused more on the spectroscopies and chemometrics in the frame of the implementation of PAT (Process Analytical Technology) in Roche’s small molecule drug development. Pascal joined LONZA’s Drug Product Services department in October 2017, and more specifically the Forensic Chemistry group. He and his co-workers are supporting the complete Lonza network and external companies in troubleshooting product deviations and foreign particle investigations. He is also supporting the Lonza Drug Product network in setting up visual inspection practices and providing test sets for training and qualification of operators and machines for biological cell and gene therapies.

• 14:50 – 15:05

  Attention to Detail – A Case Study on Particle Inspection in IV Bags

  • Co-Presenter: Thorsten Daus, Product manager, VITRONIC Dr.-Ing. Stein Bildverarbeitungssysteme GmbH

    

    Thorsten Daus, Product manager, VITRONIC Dr.-Ing. Stein Bildverarbeitungssysteme GmbH
    

    Thorsten has 20 years of experience in the industrial machine vision business in various segments including medical devices, and pharmaceutical packaging. At VITRONIC he is responsible for automated visual inspection solutions for pharmaceuticals and medical devices. In his position as a product manager, he focuses on identifying process requirements in difficult-to-inspect products and translating them into new standardized solutions.

  • Co-Presenter: Rupert Gschwendtner, Head of R&D Medical, Kiefel GmbH

    

    Rupert Gschwendtner, Head of R&D Medical, Kiefel GmbH
    

    Rupert has 25 years of experience in special purpose machinery manufacturing for production of medical and pharmaceutical packaging (mostly medical bags). At Kiefel GmbH, he is responsible for the R&D laboratory and carries out Kiefel's own developments and also product development in close cooperation with customers. He is resposible for processing technologies in Kiefel medical machines.

• 15:05 – 15:20

  Visual Inspection of Small-Volume Parenteral Products

  • Presenter: Ragunath Ananthavettivelu, Director Visual Inspection & Device Assembly, ten23 health

    

    Ragunath Ananthavettivelu, Director Visual Inspection & Device Assembly, ten23 health
    

    I studied molecular bioanalytics at the FHNW, Switzerland. I started my career at JnJ, Janssen as an Associate Scientist in Research & Development and then moved internally into QA. While working in QA, I had an interface function with production, so I took on the position of Head of Visual Inspection at Swissfillon AG and then Director of Visual Inspection and Device Assembly at ten23 health.

• 15:20 – 15:55

  Q&A, Discussion

  • Moderator: Andrea A Sardella, PhD, Product Development Manager, Stevanato Group

    

    Andrea A Sardella, PhD, Product Development Manager, Stevanato Group
    

    Andrea holds a degree in Physics from Padua University and a Master's in Nuclear Engineering.
    
    As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE).
    
    After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools.
    
    He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines.
    
    Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

  • Panelist: Ragunath Ananthavettivelu, Director Visual Inspection & Device Assembly, ten23 health

    

    Ragunath Ananthavettivelu, Director Visual Inspection & Device Assembly, ten23 health
    

    I studied molecular bioanalytics at the FHNW, Switzerland. I started my career at JnJ, Janssen as an Associate Scientist in Research & Development and then moved internally into QA. While working in QA, I had an interface function with production, so I took on the position of Head of Visual Inspection at Swissfillon AG and then Director of Visual Inspection and Device Assembly at ten23 health.

  • Panelist: Pascal Chalus, PhD, Associate Director, Lonza AG

    

    Pascal Chalus, PhD, Associate Director, Lonza AG
    

    Pascal is a chemist by training from the University of Haute Alsace (France). He acquired a PhD by applying near-infrared spectroscopy and innovative chemometric tools for the determination of drug content in low-dosed narcotics tablets at F. Hoffman-La Roche. Pascal worked then for 9 years in small molecule development of F. Hoffman-La Roche, implementing vibrational spectroscopies and imaging technologies in drug product development. He then focused more on the spectroscopies and chemometrics in the frame of the implementation of PAT (Process Analytical Technology) in Roche’s small molecule drug development. Pascal joined LONZA’s Drug Product Services department in October 2017, and more specifically the Forensic Chemistry group. He and his co-workers are supporting the complete Lonza network and external companies in troubleshooting product deviations and foreign particle investigations. He is also supporting the Lonza Drug Product network in setting up visual inspection practices and providing test sets for training and qualification of operators and machines for biological cell and gene therapies.

  • Panelist: Thorsten Daus, Product manager, VITRONIC Dr.-Ing. Stein Bildverarbeitungssysteme GmbH

    

    Thorsten Daus, Product manager, VITRONIC Dr.-Ing. Stein Bildverarbeitungssysteme GmbH
    

    Thorsten has 20 years of experience in the industrial machine vision business in various segments including medical devices, and pharmaceutical packaging. At VITRONIC he is responsible for automated visual inspection solutions for pharmaceuticals and medical devices. In his position as a product manager, he focuses on identifying process requirements in difficult-to-inspect products and translating them into new standardized solutions.

  • Panelist: Rupert Gschwendtner, Head of R&D Medical, Kiefel GmbH

    

    Rupert Gschwendtner, Head of R&D Medical, Kiefel GmbH
    

    Rupert has 25 years of experience in special purpose machinery manufacturing for production of medical and pharmaceutical packaging (mostly medical bags). At Kiefel GmbH, he is responsible for the R&D laboratory and carries out Kiefel's own developments and also product development in close cooperation with customers. He is resposible for processing technologies in Kiefel medical machines.

Networking Coffee Break, Poster Session & Exhibition

Eventfoyer

Session 3: Manual Visual Inspection

Room Ludwig-Alois

• Moderator: Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA

  

  Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA
  

  Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined the FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II, where he conducts FDA policies and program development activities related to pharmaceutical quality. Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker at multiple conferences in the area of visible and subvisible particulate testing in the past few years. He has published in peer-reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also served as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.

• 16:25 – 16:50

  Counterintuitive Thinking: Why Accept on Zero Sampling Plans Allow MORE Defects to be Released

  • Presenter: Richard Monell, Principal Engineer, Baxter Healthcare

    

    Richard Monell, Principal Engineer, Baxter Healthcare
    

    Richard is a Principal Engineer for Baxter Healthcare and has been with the company for 7 years. He has held various roles in manufacturing engineering and global quality and currently sits on the Global Quality Operations and Strategy team. He is an expert in validation and GMP with a focus on in-process control optimization including the reduction of process interruptions for both pharmaceutical and device manufacturing facilities. Richard holds a Bachelor of Mechanical Engineering from Auburn University.

• 16:50 – 17:10

  An Innovative Idea to Combine Visual Inspection with Compendial Method Testing

  • Co-Presenter: Susanne Gawenda, PhD, Senior Quality Control Expert, Analytical Science, Roche Diagnostics GmbH Mannheim

    

    Susanne Gawenda, PhD, Senior Quality Control Expert, Analytical Science, Roche Diagnostics GmbH Mannheim
    

    Susanne Gawenda studied chemistry with a focus on biochemistry at the Technical University Dresden, Germany, and did her Ph.D. in Biology on molecular biology and protein chemistry at the University of Ulm, Germany. Susanne Gawenda joined Roche in 2009 as a Scientist in Research & Technology in Diabetes Care Mannheim where she developed activity and stability tests to assess blood glucose levels. After joining Pharma Mannheim commercial Quality Control in 2013 she had roles with increasing responsibility and scope including analytical transfers, stability of bio-drug products, pre-approval inspections, and Q&A with health authorities. Leading a QC stability lab team under cGMP compliance, and serving as QC product manager for various bio-drug products increased her process knowledge in commercial quality control. In 2018 Susanne started serving in a global role (control strategy scientist) for bio-drug products to provide protein-scientific and analytical-technical contributions for global submission and network projects in the control system strategy areas. In this role, Susanne takes care of innovative technologies in the real-time release environment within Roche from an analytical point of view which includes the collaboration with Stefanato group. Susanne enjoys spending time with her family as well as horse riding and gardening.

  • Co-Presenter: Andrea A Sardella, PhD, Product Development Manager, Stevanato Group

    

    Andrea A Sardella, PhD, Product Development Manager, Stevanato Group
    

    Andrea holds a degree in Physics from Padua University and a Master's in Nuclear Engineering.
    
    As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE).
    
    After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools.
    
    He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines.
    
    Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

• 17:10 – 17:45

  Q&A, Discussion

  • Moderator: Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA

    

    Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA
    

    Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined the FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II, where he conducts FDA policies and program development activities related to pharmaceutical quality. Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker at multiple conferences in the area of visible and subvisible particulate testing in the past few years. He has published in peer-reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also served as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.

  • Panelist: Susanne Gawenda, PhD, Senior Quality Control Expert, Analytical Science, Roche Diagnostics GmbH Mannheim

    

    Susanne Gawenda, PhD, Senior Quality Control Expert, Analytical Science, Roche Diagnostics GmbH Mannheim
    

    Susanne Gawenda studied chemistry with a focus on biochemistry at the Technical University Dresden, Germany, and did her Ph.D. in Biology on molecular biology and protein chemistry at the University of Ulm, Germany. Susanne Gawenda joined Roche in 2009 as a Scientist in Research & Technology in Diabetes Care Mannheim where she developed activity and stability tests to assess blood glucose levels. After joining Pharma Mannheim commercial Quality Control in 2013 she had roles with increasing responsibility and scope including analytical transfers, stability of bio-drug products, pre-approval inspections, and Q&A with health authorities. Leading a QC stability lab team under cGMP compliance, and serving as QC product manager for various bio-drug products increased her process knowledge in commercial quality control. In 2018 Susanne started serving in a global role (control strategy scientist) for bio-drug products to provide protein-scientific and analytical-technical contributions for global submission and network projects in the control system strategy areas. In this role, Susanne takes care of innovative technologies in the real-time release environment within Roche from an analytical point of view which includes the collaboration with Stefanato group. Susanne enjoys spending time with her family as well as horse riding and gardening.

  • Panelist: Richard Monell, Principal Engineer, Baxter Healthcare

    

    Richard Monell, Principal Engineer, Baxter Healthcare
    

    Richard is a Principal Engineer for Baxter Healthcare and has been with the company for 7 years. He has held various roles in manufacturing engineering and global quality and currently sits on the Global Quality Operations and Strategy team. He is an expert in validation and GMP with a focus on in-process control optimization including the reduction of process interruptions for both pharmaceutical and device manufacturing facilities. Richard holds a Bachelor of Mechanical Engineering from Auburn University.

  • Panelist: Andrea A Sardella, PhD, Product Development Manager, Stevanato Group

    

    Andrea A Sardella, PhD, Product Development Manager, Stevanato Group
    

    Andrea holds a degree in Physics from Padua University and a Master's in Nuclear Engineering.
    
    As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE).
    
    After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools.
    
    He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines.
    
    Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

End of Conference Day 1 & Networking Event

Registration Open

Eventfoyer

Welcome to Day 2

Room Ludwig-Alois

• Co-Chair: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

  

  John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
  

  John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology. John holds a BS in Chemistry from Carroll College and a PhD in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and is leading the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods, and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.

• Co-Chair: Romain Veillon, PharmD, Director Vision Technology MSAT, GSK

  

  Romain Veillon, PharmD, Director Vision Technology MSAT, GSK
  

  Romain Veillon is Director of Vision Technology at GSK, in Global MSAT Device and Aspetic Technologies. As a global expert, he is leading the Visual Inspection and leak detection performance and expertise network on multiple sites. Romain is leading a global team to manufacture and supply defect kits and; trend defects across GSK sites. He focuses on Quality Integration, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement, and Develop Equipment strategy within the network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing on Digitalization and innovation management with new AVI-LT asset deployment. Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment. Last past 25 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly, and GSK, in support of production and secondary operations projects for filling and freeze-drying. He also developed innovative vision systems with some academic collaborations and regular presentations at PDA conferences. In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain has been Interest Group Leader for Visual Inspection in PDA Europe and co-chairing the US and Europe PDA VI Forum. In 2020 Romain received the PDA James P. Agalloco Award for educational training.

Session 4: Automation in Visual Inspection & Artificial Intelligence

Room Ludwig-Alois

• Moderator: Romain Veillon, PharmD, Director Vision Technology MSAT, GSK

  

  Romain Veillon, PharmD, Director Vision Technology MSAT, GSK
  

  Romain Veillon is Director of Vision Technology at GSK, in Global MSAT Device and Aspetic Technologies. As a global expert, he is leading the Visual Inspection and leak detection performance and expertise network on multiple sites. Romain is leading a global team to manufacture and supply defect kits and; trend defects across GSK sites. He focuses on Quality Integration, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement, and Develop Equipment strategy within the network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing on Digitalization and innovation management with new AVI-LT asset deployment. Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment. Last past 25 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly, and GSK, in support of production and secondary operations projects for filling and freeze-drying. He also developed innovative vision systems with some academic collaborations and regular presentations at PDA conferences. In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain has been Interest Group Leader for Visual Inspection in PDA Europe and co-chairing the US and Europe PDA VI Forum. In 2020 Romain received the PDA James P. Agalloco Award for educational training.

• 09:05 – 09:20

  Deep Learning for Enhanced AVI Detection Combined with Rule-Based Image Sequence Tracking for False Fail Reduction

  • Co-Presenter: Al Goodwin, B.Sc (Eng.) HDip, PRINCIPAL ENGINEER, AMGEN

    

    Al Goodwin, B.Sc (Eng.) HDip, PRINCIPAL ENGINEER, AMGEN
    

    Al Goodwin, B.Sc. (Eng.) HDip is a Principal Engineer at AMGEN. He has designed and implemented visual inspection systems over the last 25 years. He specifies and supports globally Amgen’s AVI systems for vials, syringes, plastic cartridges, and drug delivery devices. He has worked in Japan for 5 years on optical test measurement systems and at the Engineering Director level at inspection design companies based in Europe. In the last 15 years, he has worked closely with key International Machine Vision Software design companies and has used this experience in areas of optimization of particle detection, Glass flaw detection, and improvements, and evaluation of Vision Algorithm Robustness in the Biotech & pharmaceutical industries. In the last 5 years, his focus has been on how to achieve truly optimized AVI systems, not only by technology choice but understanding the key parameters that are responsible for AVI systems failures and introducing new embedded software to monitor these key parameters in real-time.

  • Co-Presenter: Wolfgang Brandenburger, Dipl.-Ing., Data Scientist Inspection Systems Development, Körber Pharma

    

    Wolfgang Brandenburger, Dipl.-Ing., Data Scientist Inspection Systems Development, Körber Pharma
    

    Between 2008 and 2012, I studied Geodesy and Geoinformation at the University of the Bundeswehr Munich and graduated as Diplom-Ingenieur (Dipl.-Ing.). Subsequently, I worked from 2012 to 2018 at various scientific departments within the federal armed forces, including the Bundeswehr Geoinformation Centre in Euskirchen and the University of the Bundeswehr in Munich in the field of mobile mapping, photogrammetry, and 3D data processing. In 2018, I joined the Institute for Applied Science at the University of the Bundeswehr as a research assistant. My focus shifted toward the exploration of multi-task deep neural networks, specifically in the application of satellite imagery analysis. This role allowed me to delve deep into the nuances of artificial intelligence, enhancing my proficiency in leveraging AI for complex image-processing tasks. Since 2022, I have been part of Koerber Pharma Inspection in Markt Schwaben, holding the position of Senior Data Scientist. My current responsibilities involve applying cutting-edge deep learning techniques to the visual inspection of pharmaceutical products. This role not only allows me to contribute to the safety and efficacy of pharmaceuticals but also enables me to push the boundaries of machine learning applications in the industry, ensuring the highest quality standards are met through innovative technological solutions.

• 09:20 – 09:35

  Navigating the Black Box: Monitoring and Explaining Deep Learning Models for AVI

  • Co-Presenter: Ioanna Psylla, MSc, Technical Product Owner, Novo Nordisk

    

    Ioanna Psylla, MSc, Technical Product Owner, Novo Nordisk
    

    Ioanna Psylla leads the design and implementation of cutting-edge technologies for optimizing manufacturing processes in Novo Nordisk. Her career, extending over 7 years, covers a wide array of digital solutions, denoting a profound understanding of artificial intelligence and its versatile applications across different industries such as banking, healthcare, manufacturing, and public safety. Her passion lies in driving innovation and efficiency within drug manufacturing.

  • Co-Presenter: Michal Stepien, MSc, OT Data Engineer, Novo Nordisk

    

    Michal Stepien, MSc, OT Data Engineer, Novo Nordisk
    

    My name is Michał Stępień and I work as an OT Data Engineer in Novo Nordisk. I have a background in Manufacturing and Operations Engineering as well as Computer Science. As a member of the ImageNN team (AVI project), I manage the ImageNN monitoring platform to provide insight into the performance of the deep learning models responsible for automated visual inspection. Besides this project, I provide intelligent solutions for manufacturing in Novo Nordisk.

• 09:35 – 09:50

  Unlocking Potential: AI-Powered Visual Inspection in Commercial Use

  • Co-Presenter: Mario Holl, MSc, PhD, Managing Director, InspectifAI GmbH

    

    Mario Holl, MSc, PhD, Managing Director, InspectifAI GmbH
    

    Today - October 2021 Managing Director of InspectifAI, a corporate venture of the Körber Group, focusing on developing the machine-agnostic software platform to bring AI to every automatic visual inspection machine in Pharma. Responsible for all product and commercial topics. December 2021 – August 2017 Several stations within the Digital Transformation Journey of Körber Pharma. As Chief Digital Officer responsible for the overall digital portfolio of Körber Pharma. Definition and Design of the corporate venture InspectifAI to build on top of the inspection competence of Körber Pharma. August 2017 – 2009 Bachelor of Science, Master of Science, and PhD in Mechanical Engineering at Technische Universität Darmstadt.

  • Co-Presenter: Alessandra Corbisiero, Automation &CSV Manager, Patheon, by Thermo Fisher Scientific

    

    Alessandra Corbisiero, Automation &CSV Manager, Patheon, by Thermo Fisher Scientific
    

    Alessandra Corbisiero, Automation Engineering & CSV Manager 30 years in the Pharmaceutical industry with main experience in the Computer Validation area. Worked both as a contractor and as an internal resource for large pharma, CMO, and MES development company In Thermofisher Scientific since 2011 moving from CSV to the Manufacturing Computer System expert. Current role Automation and CSV manager reporting to the Engineering department.

• 09:50 – 10:25

  Q&A, Discussion

  • Moderator: Romain Veillon, PharmD, Director Vision Technology MSAT, GSK

    

    Romain Veillon, PharmD, Director Vision Technology MSAT, GSK
    

    Romain Veillon is Director of Vision Technology at GSK, in Global MSAT Device and Aspetic Technologies. As a global expert, he is leading the Visual Inspection and leak detection performance and expertise network on multiple sites. Romain is leading a global team to manufacture and supply defect kits and; trend defects across GSK sites. He focuses on Quality Integration, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement, and Develop Equipment strategy within the network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing on Digitalization and innovation management with new AVI-LT asset deployment. Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment. Last past 25 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly, and GSK, in support of production and secondary operations projects for filling and freeze-drying. He also developed innovative vision systems with some academic collaborations and regular presentations at PDA conferences. In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain has been Interest Group Leader for Visual Inspection in PDA Europe and co-chairing the US and Europe PDA VI Forum. In 2020 Romain received the PDA James P. Agalloco Award for educational training.

  • Panelist: Wolfgang Brandenburger, Dipl.-Ing., Data Scientist Inspection Systems Development, Körber Pharma

    

    Wolfgang Brandenburger, Dipl.-Ing., Data Scientist Inspection Systems Development, Körber Pharma
    

    Between 2008 and 2012, I studied Geodesy and Geoinformation at the University of the Bundeswehr Munich and graduated as Diplom-Ingenieur (Dipl.-Ing.). Subsequently, I worked from 2012 to 2018 at various scientific departments within the federal armed forces, including the Bundeswehr Geoinformation Centre in Euskirchen and the University of the Bundeswehr in Munich in the field of mobile mapping, photogrammetry, and 3D data processing. In 2018, I joined the Institute for Applied Science at the University of the Bundeswehr as a research assistant. My focus shifted toward the exploration of multi-task deep neural networks, specifically in the application of satellite imagery analysis. This role allowed me to delve deep into the nuances of artificial intelligence, enhancing my proficiency in leveraging AI for complex image-processing tasks. Since 2022, I have been part of Koerber Pharma Inspection in Markt Schwaben, holding the position of Senior Data Scientist. My current responsibilities involve applying cutting-edge deep learning techniques to the visual inspection of pharmaceutical products. This role not only allows me to contribute to the safety and efficacy of pharmaceuticals but also enables me to push the boundaries of machine learning applications in the industry, ensuring the highest quality standards are met through innovative technological solutions.

  • Panelist: Alessandra Corbisiero, Automation &CSV Manager, Patheon, by Thermo Fisher Scientific

    

    Alessandra Corbisiero, Automation &CSV Manager, Patheon, by Thermo Fisher Scientific
    

    Alessandra Corbisiero, Automation Engineering & CSV Manager 30 years in the Pharmaceutical industry with main experience in the Computer Validation area. Worked both as a contractor and as an internal resource for large pharma, CMO, and MES development company In Thermofisher Scientific since 2011 moving from CSV to the Manufacturing Computer System expert. Current role Automation and CSV manager reporting to the Engineering department.

  • Panelist: Al Goodwin, B.Sc (Eng.) HDip, PRINCIPAL ENGINEER, AMGEN

    

    Al Goodwin, B.Sc (Eng.) HDip, PRINCIPAL ENGINEER, AMGEN
    

    Al Goodwin, B.Sc. (Eng.) HDip is a Principal Engineer at AMGEN. He has designed and implemented visual inspection systems over the last 25 years. He specifies and supports globally Amgen’s AVI systems for vials, syringes, plastic cartridges, and drug delivery devices. He has worked in Japan for 5 years on optical test measurement systems and at the Engineering Director level at inspection design companies based in Europe. In the last 15 years, he has worked closely with key International Machine Vision Software design companies and has used this experience in areas of optimization of particle detection, Glass flaw detection, and improvements, and evaluation of Vision Algorithm Robustness in the Biotech & pharmaceutical industries. In the last 5 years, his focus has been on how to achieve truly optimized AVI systems, not only by technology choice but understanding the key parameters that are responsible for AVI systems failures and introducing new embedded software to monitor these key parameters in real-time.

  • Panelist: Mario Holl, MSc, PhD, Managing Director, InspectifAI GmbH

    

    Mario Holl, MSc, PhD, Managing Director, InspectifAI GmbH
    

    Today - October 2021 Managing Director of InspectifAI, a corporate venture of the Körber Group, focusing on developing the machine-agnostic software platform to bring AI to every automatic visual inspection machine in Pharma. Responsible for all product and commercial topics. December 2021 – August 2017 Several stations within the Digital Transformation Journey of Körber Pharma. As Chief Digital Officer responsible for the overall digital portfolio of Körber Pharma. Definition and Design of the corporate venture InspectifAI to build on top of the inspection competence of Körber Pharma. August 2017 – 2009 Bachelor of Science, Master of Science, and PhD in Mechanical Engineering at Technische Universität Darmstadt.

  • Panelist: Ioanna Psylla, MSc, Technical Product Owner, Novo Nordisk

    

    Ioanna Psylla, MSc, Technical Product Owner, Novo Nordisk}
    

    Ioanna Psylla leads the design and implementation of cutting-edge technologies for optimizing manufacturing processes in Novo Nordisk. Her career, extending over 7 years, covers a wide array of digital solutions, denoting a profound understanding of artificial intelligence and its versatile applications across different industries such as banking, healthcare, manufacturing, and public safety. Her passion lies in driving innovation and efficiency within drug manufacturing.

  • Panelist: Michal Stepien, MSc, OT Data Engineer, Novo Nordisk

    

    Michal Stepien, MSc, OT Data Engineer, Novo Nordisk
    

    My name is Michał Stępień and I work as an OT Data Engineer in Novo Nordisk. I have a background in Manufacturing and Operations Engineering as well as Computer Science. As a member of the ImageNN team (AVI project), I manage the ImageNN monitoring platform to provide insight into the performance of the deep learning models responsible for automated visual inspection. Besides this project, I provide intelligent solutions for manufacturing in Novo Nordisk.

Networking Coffee Break, Poster Session & Exhibition

Eventfoyer

Session 5: Emerging Technologies for Visual Inspection

Room Ludwig-Alois

• Moderator: Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG

  

  Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
  

  Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC, and Contract Manufacturing management, including sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.

• 10:55 – 11:20

  Reducing Inspection Complexity by Introducing Beyond-Human Sensing for Lyophilized Vaccine Inspection

  • Academic Presenter: Denise Tellbach, MA, PhD Candidate, Massachusetts Institute of Technology

    

    Denise Tellbach, MA, PhD Candidate, Massachusetts Institute of Technology
    

    Denise Tellbach is a graduate student in Mechanical Engineering at the Auto-ID Labs, Massachusetts Institute of Technology, Cambridge, MA, USA, where she is working on integrating AI with multi-modal sensing. She received a double master's degree in Management Science and Mechanical Engineering from RWTH Aachen University and Tsinghua University in 2018 and her undergraduate degree from RWTH Aachen University in 2016. She is interested in vision and radio frequency-based sensor technologies for material and defect detection in vaccine production, recycling, and picking tasks.

• 11:20 – 11:45

  Water Proton Nuclear Magnetic Resonance (wNMR) for Noninvasive Pharmaceutical Analysis

  • Academic Presenter: Bruce Yu, PhD, Professor, University of Maryland School of Pharmacy

    

    Bruce Yu, PhD, Professor, University of Maryland School of Pharmacy
    

    Dr. Bruce Yu is an Inaugural MPower Professor at the University of Maryland and the director of its Bio- and Nano-Technology Center. He is a fellow of the Institute for Bioscience and Biotechnology Research. Dr. Yu has researched biophysics, imaging agents, and biomaterials. His current focus is on noninvasive analytic technologies for pharmaceutical manufacturing and quality control. He received the 2004 Kimmel Scholar Award and the 2006 US Presidential Early Career Awards for Scientists and Engineers. He has a Ph.D. in biophysics from the Johns Hopkins University. He and his coworkers proposed the concept of Preventive Pharmacovigilance (Pharmaceutical Research, 40, 2103, 2023).

• 11:45 – 12:15

  Q&A, Discussion

  • Moderator: Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG

    

    Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
    

    Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC, and Contract Manufacturing management, including sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.

  • Panelist: Denise Tellbach, MA, PhD Candidate, Massachusetts Institute of Technology

    

    Denise Tellbach, MA, PhD Candidate, Massachusetts Institute of Technology
    

    Denise Tellbach is a graduate student in Mechanical Engineering at the Auto-ID Labs, Massachusetts Institute of Technology, Cambridge, MA, USA, where she is working on integrating AI with multi-modal sensing. She received a double master's degree in Management Science and Mechanical Engineering from RWTH Aachen University and Tsinghua University in 2018 and her undergraduate degree from RWTH Aachen University in 2016. She is interested in vision and radio frequency-based sensor technologies for material and defect detection in vaccine production, recycling, and picking tasks.

  • Panelist: Bruce Yu, PhD, Professor, University of Maryland School of Pharmacy

    

    Bruce Yu, PhD, Professor, University of Maryland School of Pharmacy
    

    Dr. Bruce Yu is an Inaugural MPower Professor at the University of Maryland and the director of its Bio- and Nano-Technology Center. He is a fellow of the Institute for Bioscience and Biotechnology Research. Dr. Yu has researched biophysics, imaging agents, and biomaterials. His current focus is on noninvasive analytic technologies for pharmaceutical manufacturing and quality control. He received the 2004 Kimmel Scholar Award and the 2006 US Presidential Early Career Awards for Scientists and Engineers. He has a Ph.D. in biophysics from the Johns Hopkins University. He and his coworkers proposed the concept of Preventive Pharmacovigilance (Pharmaceutical Research, 40, 2103, 2023).

Networking Lunch Break, Poster Session & Exhibition

Eventfoyer

Interactive Questionnaire Session

Room Ludwig-Alois

• Moderator: Herve Soukiassian, Assoc. Director – Product Development, BD

  

  Herve Soukiassian, Assoc. Director – Product Development, BD
  

  Hervé Soukiassian joined BD Medical - Pharmaceutical Systems in 2007 and is currently involved in Product Development for Prefillable Syringes for Track and Trace. Under his leadership, the BD Neopak™ XSi™ and the BD Neopak™ XtraFlow™ platforms have been successfully developed and brought to market. He has also contributed actively within the PDA as co-author of both Technical Report 85, "Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers," and Technical Report 73, "Prefilled Syringe User Requirements for Biotechnology Applications." Before joining BD, Hervé held various positions at Hewlett Packard, developing expertise in the fields of process engineering and product development for over a decade. He later joined the board of Directors of ActiCM, a start-up company specializing in optical Coordinate Measurement Machines. Hervé graduated from the Institut National des Sciences Appliquées in Lyon, France, as a mechanical and industrial engineer with a Master's Degree in material sciences.

Closing Plenary: Current and Future Perspective Part I

Room Ludwig-Alois

• Moderator: Herve Soukiassian, Assoc. Director – Product Development, BD

  

  Herve Soukiassian, Assoc. Director – Product Development, BD
  

  Hervé Soukiassian joined BD Medical - Pharmaceutical Systems in 2007 and is currently involved in Product Development for Prefillable Syringes for Track and Trace. Under his leadership, the BD Neopak™ XSi™ and the BD Neopak™ XtraFlow™ platforms have been successfully developed and brought to market. He has also contributed actively within the PDA as co-author of both Technical Report 85, "Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers," and Technical Report 73, "Prefilled Syringe User Requirements for Biotechnology Applications." Before joining BD, Hervé held various positions at Hewlett Packard, developing expertise in the fields of process engineering and product development for over a decade. He later joined the board of Directors of ActiCM, a start-up company specializing in optical Coordinate Measurement Machines. Hervé graduated from the Institut National des Sciences Appliquées in Lyon, France, as a mechanical and industrial engineer with a Master's Degree in material sciences.

• 13:30 – 13:50

  Highlights from the PDA Visual Inspection Survey 2023

  • Presenter: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    

    John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    

    John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology. John holds a BS in Chemistry from Carroll College and a PhD in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and is leading the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods, and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.

• 13:50 – 14:15

  Use Cases on Data Analytics to Increase Inspection Transparency and Machine Availability

  • Presenter: Felix Riehn, MSc, Head of Product Management, Körber Pharma

    

    Felix Riehn, MSc, Head of Product Management, Körber Pharma
    

    Felix Riehn holds a master of science degree. He joined Körber Pharma in 2014 and has worked in business development, strategic marketing, and product management. After 4 years in the Swiss headquarters, he joined the world market leader 'Körber Pharma Inspection', formerly 'Seidenader'. As head of product management, he is in constant exchange with pharmaceutical manufacturers and drove product innovations such as the 'Switch 75' or 'Deep Learning'.

Networking Coffee Break, Poster Session & Exhibition

Eventfoyer

Passport Raffle

Room Ludwig-Alois

• Moderator: Melanie Decker, Parenteral Drug Association

  

  Melanie Decker, Parenteral Drug Association
  

Closing Plenary: Current and Future Perspective Part II

Room Ludwig-Alois

• Moderator: Herve Soukiassian, Assoc. Director – Product Development, BD

  

  Herve Soukiassian, Assoc. Director – Product Development, BD
  

  Hervé Soukiassian joined BD Medical - Pharmaceutical Systems in 2007 and is currently involved in Product Development for Prefillable Syringes for Track and Trace. Under his leadership, the BD Neopak™ XSi™ and the BD Neopak™ XtraFlow™ platforms have been successfully developed and brought to market. He has also contributed actively within the PDA as co-author of both Technical Report 85, "Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers," and Technical Report 73, "Prefilled Syringe User Requirements for Biotechnology Applications." Before joining BD, Hervé held various positions at Hewlett Packard, developing expertise in the fields of process engineering and product development for over a decade. He later joined the board of Directors of ActiCM, a start-up company specializing in optical Coordinate Measurement Machines. Hervé graduated from the Institut National des Sciences Appliquées in Lyon, France, as a mechanical and industrial engineer with a Master's Degree in material sciences.

• 14:50 – 15:15

  Knowledge Management to Reach Challenging Sustainability Goals

  • Co-Presenter: Helene Vacelet, PhD, Sustainability Senior Program Manager, Becton Dickinson Pharmaceutical Systems

    

    Helene Vacelet, PhD, Sustainability Senior Program Manager, Becton Dickinson Pharmaceutical Systems
    

    Hélène Vacelet, Ph., is a Sustainability Senior Program Manager within BD Medical Pharmaceutical Systems. Since 2020, she built the sustainability product roadmap as well as eco-design and LCA internal capabilities. Before that, she drove quality engineering for 5 years on autoinjectors and safety devices and then she led the R&D PFS portfolio sustaining and technical support activities for 6 years. Before BD, Hélène held progressing positions in R&D and process engineering with STMicroelectronics, Integrated Device Manufacturer. She holds an MS in Material Science & an MS in Integrated Electronic devices from INSA Lyon and a PhD thesis in Microelectronics from Louis Paster University, Strasbourg. She is certified in “Sustainability leadership and corporate responsibility” from the London Business School.

  • Co-Presenter: Stephane Hubac, Manufacturing Science Fellow, Retired From STMicroelectronics

    

    Stephane Hubac, Manufacturing Science Fellow, Retired From STMicroelectronics
    

    I have worked in the semiconductor industry since receiving my engineering degree in physics from the Manufacturing Science Fellow (Advanced Process & Equipment Control & Knowledge Management) on transversal projects at STMicroelectronics. I am currently Chairman of the ST France Technical College Board of fellow. Associated with Grenoble University as a visiting Professor on process control and plasma physics. Special interests include R&D on DFM methods, yield enhancement, productivity, and process control. ST representative @ "Industrial Club" of Grenoble INP University and @ Grenoble IMEP-2 doctorate school. Since 1981, I have worked in many disciplines within the semiconductor industry including memory device design, manufacturing, process & equipment engineering in lithography, dry etching and dielectric deposition, process control, and Quality methods implementation in Manufacturing & R&D. I have joined 300mm CR2 Alliance (Freescale, NxP, ST) in the initial phase of the project as a project manager; responsible for the selection of 300mm plasma etching & dry stripping equipment, then manufacturing and R&D ramp-up has an AREA Manager (Etch, Strip, APC programs). I have been the leader of the CR2 Alliance APC project, ISOTS audit supervisor for Fab qualification, and Process Control Area manager in the Crolles 2 Alliance 300mm R&D facility at Crolles, France. In previous years, I have been involved in ENIAC European Project IMPROVE (WP3: Predictive Maintenance), and INTEGRATE (WP5: data Analysis & Yield). Stéphane Hubac holds an engineering degree in physics from the Marseille Physics National University (Central Marseille)

• 15:15 – 16:00

  Closing Panel Discussion

  • Moderator: Herve Soukiassian, Assoc. Director – Product Development, BD

    

    Herve Soukiassian, Assoc. Director – Product Development, BD
    

    Hervé Soukiassian joined BD Medical - Pharmaceutical Systems in 2007 and is currently involved in Product Development for Prefillable Syringes for Track and Trace. Under his leadership, the BD Neopak™ XSi™ and the BD Neopak™ XtraFlow™ platforms have been successfully developed and brought to market. He has also contributed actively within the PDA as co-author of both Technical Report 85, "Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers," and Technical Report 73, "Prefilled Syringe User Requirements for Biotechnology Applications." Before joining BD, Hervé held various positions at Hewlett Packard, developing expertise in the fields of process engineering and product development for over a decade. He later joined the board of Directors of ActiCM, a start-up company specializing in optical Coordinate Measurement Machines. Hervé graduated from the Institut National des Sciences Appliquées in Lyon, France, as a mechanical and industrial engineer with a Master's Degree in material sciences.

  • Panelist: Antonio Burazer, Global Head of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG

    

    Antonio Burazer, Global Head of Visual Inspection & Particle LCM, Takeda Pharmaceuticals International AG
    

    Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over responsibility for visual inspection and particle life cycle management globally for Takeda. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal of achieving zero particles in parenteral products.

  • Regulatory Panelist: Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA

    

    Rukman S De Silva, PhD, Policy Lead, OPQ/OPPQ/CDER, U.S. FDA
    

    Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined the FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and control (CMC) review and inspectional activities related to biological products submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II, where he conducts FDA policies and program development activities related to pharmaceutical quality. Dr. De Silva has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker at multiple conferences in the area of visible and subvisible particulate testing in the past few years. He has published in peer-reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also served as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.

  • Panelist: Stephane Hubac, Manufacturing Science Fellow, Retired From STMicroelectronics

    

    Stephane Hubac, Manufacturing Science Fellow, Retired From STMicroelectronics
    

    I have worked in the semiconductor industry since receiving my engineering degree in physics from the Manufacturing Science Fellow (Advanced Process & Equipment Control & Knowledge Management) on transversal projects at STMicroelectronics. I am currently Chairman of the ST France Technical College Board of fellow. Associated with Grenoble University as a visiting Professor on process control and plasma physics. Special interests include R&D on DFM methods, yield enhancement, productivity, and process control. ST representative @ "Industrial Club" of Grenoble INP University and @ Grenoble IMEP-2 doctorate school. Since 1981, I have worked in many disciplines within the semiconductor industry including memory device design, manufacturing, process & equipment engineering in lithography, dry etching and dielectric deposition, process control, and Quality methods implementation in Manufacturing & R&D. I have joined 300mm CR2 Alliance (Freescale, NxP, ST) in the initial phase of the project as a project manager; responsible for the selection of 300mm plasma etching & dry stripping equipment, then manufacturing and R&D ramp-up has an AREA Manager (Etch, Strip, APC programs). I have been the leader of the CR2 Alliance APC project, ISOTS audit supervisor for Fab qualification, and Process Control Area manager in the Crolles 2 Alliance 300mm R&D facility at Crolles, France. In previous years, I have been involved in ENIAC European Project IMPROVE (WP3: Predictive Maintenance), and INTEGRATE (WP5: data Analysis & Yield). Stéphane Hubac holds an engineering degree in physics from the Marseille Physics National University (Central Marseille)

  • Panelist: Irene Kraemer, PhD, Director Department of Pharmacy, University Medical Center, Johannes Gutenberg-University Mainz

    

    Irene Kraemer, PhD, Director Department of Pharmacy, University Medical Center, Johannes Gutenberg-University Mainz
    

    Irene Krämer, PharmD, PhD, is Director of the Pharmacy Department of the University Medical Center at the Johannes Gutenberg-University Mainz (Germany) and Professor of Clinical Pharmacy at the faculty of pharmacy at the same university. She obtained her doctorate in pharmaceutical chemistry and continued her postgraduate education at the Pharmacy Department of the Johannes Gutenberg University and went on to complete her postdoctoral thesis in Pharmaceutical Technology, entitled 'Development, Quality Assurance, and Optimization of Ready-to-Use Parenteral Solutions in the Integrated Cancer Care Concept'. The research projects of Prof. Kraemer focus on experimental studies of the physicochemical and microbiological stability of ready-to-administer parenteral preparations mainly used in oncology and intensive care patients. Other research projects deal with the development and evaluation of clinical pharmacy services and the improvement of medication safety by digitalization and automation of the medication process. She also performed numerous studies regarding medication adherence in special patient groups. Prof. Krämer published numerous scientific papers and is the author/editor of several clinical pharmacy and pharmaceutical technology textbooks. She received the German Federal Cross of Merit for her dedication to clinical pharmacy and patient care.

  • Panelist: Felix Riehn, MSc, Head of Product Management, Körber Pharma

    

    Felix Riehn, MSc, Head of Product Management, Körber Pharma}
    

    Felix Riehn holds a master of science degree. He joined Körber Pharma in 2014 and has worked in business development, strategic marketing, and product management. After 4 years in the Swiss headquarters, he joined the world market leader 'Körber Pharma Inspection', formerly 'Seidenader'. As head of product management, he is in constant exchange with pharmaceutical manufacturers and drove product innovations such as the 'Switch 75' or 'Deep Learning'.

  • Panelist: Helene Vacelet, PhD, Sustainability Senior Program Manager, Becton Dickinson Pharmaceutical Systems

    

    Helene Vacelet, PhD, Sustainability Senior Program Manager, Becton Dickinson Pharmaceutical Systems
    

    Hélène Vacelet, Ph., is a Sustainability Senior Program Manager within BD Medical Pharmaceutical Systems. Since 2020, she built the sustainability product roadmap as well as eco-design and LCA internal capabilities. Before that, she drove quality engineering for 5 years on autoinjectors and safety devices and then she led the R&D PFS portfolio sustaining and technical support activities for 6 years. Before BD, Hélène held progressing positions in R&D and process engineering with STMicroelectronics, Integrated Device Manufacturer. She holds an MS in Material Science & an MS in Integrated Electronic devices from INSA Lyon and a PhD thesis in Microelectronics from Louis Paster University, Strasbourg. She is certified in “Sustainability leadership and corporate responsibility” from the London Business School.

Co-Chairs Conference Summary

Room Ludwig-Alois

• Co-Chair: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

  

  John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
  

  John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology. John holds a BS in Chemistry from Carroll College and a PhD in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and is leading the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods, and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.

• Co-Chair: Romain Veillon, PharmD, Director Vision Technology MSAT, GSK

  

  Romain Veillon, PharmD, Director Vision Technology MSAT, GSK
  

  Romain Veillon is Director of Vision Technology at GSK, in Global MSAT Device and Aspetic Technologies. As a global expert, he is leading the Visual Inspection and leak detection performance and expertise network on multiple sites. Romain is leading a global team to manufacture and supply defect kits and; trend defects across GSK sites. He focuses on Quality Integration, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement, and Develop Equipment strategy within the network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing on Digitalization and innovation management with new AVI-LT asset deployment. Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment. Last past 25 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly, and GSK, in support of production and secondary operations projects for filling and freeze-drying. He also developed innovative vision systems with some academic collaborations and regular presentations at PDA conferences. In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain has been Interest Group Leader for Visual Inspection in PDA Europe and co-chairing the US and Europe PDA VI Forum. In 2020 Romain received the PDA James P. Agalloco Award for educational training.

Introduction to Site Visit at the Körber Pharma Facility

Room Ludwig-Alois

• Presenter: Rupert Depner, Dipl Ing, Area Sales Manager, Körber Pharma Inspection GmbH

  

  Rupert Depner, Dipl Ing, Area Sales Manager, Körber Pharma Inspection GmbH
  

  Area Sales Manager Körber Pharma Inspection GmbH (formerly Seidenader Maschinenbau GmbH) Lilienthalstr. 8, 85570 Markt Schwaben / Germany Tel.: +49 8121 802-260, Fax: +49 8121 802-100 Rupert.depner@koerber.com www.koerber-pharma.com Biography: Born 1984 in Germany Visited the University of Applied Science in Kempten and graduated in 2010 as Dipl.-Ing. FH (economic engineering). 2010 he started as a project engineer at Seidenader Maschinenbau GmbH. From 2012 to 2016 he was responsible as a project manager at Seidenader Maschinenbau GmbH for various projects in the field of semi- and fully automated inspection machines around the globe. 2017 he moved into the sales team and as an area sales manager for inspection machines at Körber Pharma Inspection GmbH (formerly Seidenader) he is now responsible for the sales areas Germany and a global sales key account

Closing Remarks & Farewell

Room Ludwig-Alois

• Committee Member: Falk Klar, PhD, Parenteral Drug Association

  

  Falk Klar, PhD, Parenteral Drug Association
  

  Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.