PDA Annex 1 Workshop 2024

Registration Open

Heather Suite B & Foyer

Welcoming

Heather Suite A

• Committee Member: Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association

  

  Falk Klar, PhD, General Manager, Vice President Europe, 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 Remarks from Workshop Co-Chairs

Heather Suite A

• Co-Chair: Tracy Moore, Director, TM Pharma Group Ltd

  

  Tracy Moore, Director, TM Pharma Group Ltd
  

  Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

• Co-Chair: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

  

  Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
  

  Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

P1: EU GMP Annex 1 Implementation – A Regulator’s Perspective

Heather Suite A

• Moderator: Tracy Moore, Director, TM Pharma Group Ltd

  

  Tracy Moore, Director, TM Pharma Group Ltd
  

  Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

• 09:20 – 09:45

  EU GMP Annex 1, Implementation and Interpretation from an Authority Perspective

  • Regulatory Presenter: Thomas Vestergaard Pedersen

    

    Thomas Vestergaard Pedersen
    

• 09:45 – 10:10

  Two Years On: Progress and Insights on the Application of Annex 1

  • Regulatory Presenter: Aedin Hogan

    

    Aedin Hogan
    

• 10:10 – 10:40

  Plenary Discussion

  • Moderator: Tracy Moore, Director, TM Pharma Group Ltd

    

    Tracy Moore, Director, TM Pharma Group Ltd
    

    Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

  • Regulatory Panelist: Thomas Vestergaard Pedersen

    

    Thomas Vestergaard Pedersen
    

  • Panelist: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

    

    Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
    

    Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US. Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

  • Regulatory Panelist: Aedin Hogan

    

    Aedin Hogan
    

Networking Coffee Break, Poster Session & Exhibition

Heather Suite B & Foyer

P2: Quality Risk Management & Knowledge Management

Heather Suite A

• Moderator: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

  

  Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
  

  Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

• 11:10 – 11:30

  Ensuring Patient Safety: Integrating QRM and Risk-Based Decision Making to Meet Annex 1 Requirements

  • Presenter: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    

    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at  amcfarland@valsource.com.

• 11:30 – 11:50

  Knowledge Management in Pharmaceutical Manufacturing

  • Presenter: Melanie J. Adams, BSc, HDip, Associate Director, MSD

    

    Melanie J. Adams, BSc, HDip, Associate Director, MSD
    

    Melanie Adams, Associate Director, Knowledge Management Center of Excellence, MSD Knowledge Management Expert | Innovation Coach | Scientist | Dyslexic Thinker Passionate about fostering innovation and excellence, I serve as an Associate Director at MSD Pharmaceuticals, leading the deployment and design of KM strategies as a member of the Knowledge Management Center of Excellence. With a strong background in developing and implementing robust KM practices, I am dedicated to driving productivity, compliance, and continuous improvement across our global teams. 🎓 Achieved a BSc from Maynooth University, First Class Honours in UCC’s Leadership Development Higher Diploma, and currently working on my MBA in Leadership in Life Sciences with TU Dublin, all equipping me with advanced leadership skills and strategic insights. 🚀 PGS Innovation Coach: Trained to facilitate dynamic innovation sessions remotely and on-site, enabling teams to harness their creative potential and solve complex challenges. 💡 Knowledge Management Lead: At Pfizer Grange Castle, I embedded KM practices within all teams, ensuring seamless integration of innovative solutions and digital technologies. 🔬 Technical Expertise: Providing leadership to the product testing team, I have experience overseeing analytical results approval, leading investigations, and ensuring compliance with stringent quality systems. 🤝 Collaborative Leader: I work closely with digital teams to develop new KM solutions, support manufacturing sites, and contribute to technical work in validation and troubleshooting. 🌍 Global Impact: From leading site-level and network-level innovation sessions to participating in international forums and authoring industry guidelines, I am committed to advancing the field of Knowledge Management.

• 11:50 – 12:05

  Q&A

  • Moderator: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

  • Panelist: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    

    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at  amcfarland@valsource.com.

  • Panelist: Melanie J. Adams, BSc, HDip, Associate Director, MSD

    

    Melanie J. Adams, BSc, HDip, Associate Director, MSD
    

    Melanie Adams, Associate Director, Knowledge Management Center of Excellence, MSD Knowledge Management Expert | Innovation Coach | Scientist | Dyslexic Thinker Passionate about fostering innovation and excellence, I serve as an Associate Director at MSD Pharmaceuticals, leading the deployment and design of KM strategies as a member of the Knowledge Management Center of Excellence. With a strong background in developing and implementing robust KM practices, I am dedicated to driving productivity, compliance, and continuous improvement across our global teams. 🎓 Achieved a BSc from Maynooth University, First Class Honours in UCC’s Leadership Development Higher Diploma, and currently working on my MBA in Leadership in Life Sciences with TU Dublin, all equipping me with advanced leadership skills and strategic insights. 🚀 PGS Innovation Coach: Trained to facilitate dynamic innovation sessions remotely and on-site, enabling teams to harness their creative potential and solve complex challenges. 💡 Knowledge Management Lead: At Pfizer Grange Castle, I embedded KM practices within all teams, ensuring seamless integration of innovative solutions and digital technologies. 🔬 Technical Expertise: Providing leadership to the product testing team, I have experience overseeing analytical results approval, leading investigations, and ensuring compliance with stringent quality systems. 🤝 Collaborative Leader: I work closely with digital teams to develop new KM solutions, support manufacturing sites, and contribute to technical work in validation and troubleshooting. 🌍 Global Impact: From leading site-level and network-level innovation sessions to participating in international forums and authoring industry guidelines, I am committed to advancing the field of Knowledge Management.

Breakout Session 1

Heather Suite A

Networking Lunch Break, Poster Session & Exhibition

Heather Suite B & Foyer

P3: Cleanroom Design & Barrier System Integration

Heather Suite A

• Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

  

  Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
  

  Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US. Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

• 13:50 – 14:10

  Cleanroom Design

  • Presenter: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

• 14:10 – 14:30

  Barrier Systems

  • Presenter: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    

    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
    

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

• 14:30 – 14:45

  Q&A

  • Panelist: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    

    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
    

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

  • Panelist: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

  • Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

    

    Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
    

    Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US. Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

Breakout Session 2

Heather Suite A

Networking Coffee Break, Poster Session & Exhibition

Heather Suite B & Foyer

P4: Material Transfer & Decontamination

Heather Suite A

• Moderator: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments

  

  Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
  

  Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.

• 16:00 – 16:20

  Material Transfer – Overcoming the Challenge

  • Presenter: Laura Brennan, Director of Technical Consulting, Ecolab

    

    Laura Brennan, Director of Technical Consulting, Ecolab
    

    Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is the Director of Technical Consulting at Ecolab Life Sciences. She has worked for Ecolab for several years and has held various roles within the technical consulting team. She currently leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

• 16:20 – 16:40

  Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces

  • Presenter: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    

    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
    

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

• 16:40 – 16:55

  Q&A

  • Panelist: Laura Brennan, Director of Technical Consulting, Ecolab

    

    Laura Brennan, Director of Technical Consulting, Ecolab
    

    Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is the Director of Technical Consulting at Ecolab Life Sciences. She has worked for Ecolab for several years and has held various roles within the technical consulting team. She currently leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

  • Panelist: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    

    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
    

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

  • Moderator: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments

    

    Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
    

    Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.

Breakout Session 3

Heather Suite A

Day 1 Wrap Up

Heather Suite A

• Presenter: Tracy Moore, Director, TM Pharma Group Ltd

  

  Tracy Moore, Director, TM Pharma Group Ltd
  

  Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

Networking Reception

Heather Suite A

Registration Open

Heather Suite B & Foyer

P5: Personnel

Heather Suite A

• Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK

  

  Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
  

  Kurt Jaecques is the Global Aseptic Technologies lead for Monitoring and Control at GSK and has been working within the pharmaceutical Industry for more than 30 years. He holds a Master's degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring, Bioburden Controlled Manufacturing and clean Utilities in particular. He co-chaired the update of the PDA TR13 on Environmental Monitoring and is PDA IG co-lead for Microbiology and Environmental Monitoring.

• 08:20 – 08:40

  Training and Personnel Qualification

  • Presenter: Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS

    

    Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS
    

    With 28 years of experience in sterile manufacturing, Maria has held various pivotal roles, in operations, aseptic lead, and technical operations lead for a recent high-potency facility startup. She has been instrumental in numerous startup facilities, guiding them from greenfield projects to full-scale commercial manufacturing. Currently, Maria serves in a global aseptic microbial SME for ExM and Internal sites, leveraging her extensive expertise to ensure the highest standards of aseptic processing and microbial control. Maria is also the founder and chair of the Ireland Sterile Manufacturing Community of Practice (COP). What began with just two sites has now grown to include over 40 sites, reflecting her commitment to fostering collaboration and excellence within the industry.

• 08:40 – 09:00

  Gowning & Personnel Monitoring

  • Presenter: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Cell & Gene Therapy, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

• 09:00 – 09:15

  Q&A

  • Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK

    

    Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
    

    Kurt Jaecques is the Global Aseptic Technologies lead for Monitoring and Control at GSK and has been working within the pharmaceutical Industry for more than 30 years. He holds a Master's degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring, Bioburden Controlled Manufacturing and clean Utilities in particular. He co-chaired the update of the PDA TR13 on Environmental Monitoring and is PDA IG co-lead for Microbiology and Environmental Monitoring.

  • Panelist: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Cell & Gene Therapy, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

  • Panelist: Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS

    

    Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS
    

    With 28 years of experience in sterile manufacturing, Maria has held various pivotal roles, in operations, aseptic lead, and technical operations lead for a recent high-potency facility startup. She has been instrumental in numerous startup facilities, guiding them from greenfield projects to full-scale commercial manufacturing. Currently, Maria serves in a global aseptic microbial SME for ExM and Internal sites, leveraging her extensive expertise to ensure the highest standards of aseptic processing and microbial control. Maria is also the founder and chair of the Ireland Sterile Manufacturing Community of Practice (COP). What began with just two sites has now grown to include over 40 sites, reflecting her commitment to fostering collaboration and excellence within the industry.

Breakout Session 4

Heather Suite A

Networking Coffee Break, Poster Session & Exhibition

Heather Suite B & Foyer

P6: Aseptic Processing & Pre-Use Post Sterilization Integrity Testing (PUPSIT)

Heather Suite A

• Moderator: Laura Brennan, Director of Technical Consulting, Ecolab

  

  Laura Brennan, Director of Technical Consulting, Ecolab
  

  Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is the Director of Technical Consulting at Ecolab Life Sciences. She has worked for Ecolab for several years and has held various roles within the technical consulting team. She currently leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

• 10:30 – 10:50

  Aseptic Processing 1

  • Presenter: Tracy Moore, Director, TM Pharma Group Ltd

    

    Tracy Moore, Director, TM Pharma Group Ltd
    

    Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

• 10:50 – 11:10

  Aseptic Processing 2

  • Presenter: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

• 11:10 – 11:25

  Q&A

  • Moderator: Laura Brennan, Director of Technical Consulting, Ecolab

    

    Laura Brennan, Director of Technical Consulting, Ecolab
    

    Laura Brennan has previously worked as a Pharmaceutical Microbiologist, primarily with the manufacture of terminally sterilized products. She has also worked with government run agencies, monitoring and ensuring environmental microbiological standards are being maintained. Laura is the Director of Technical Consulting at Ecolab Life Sciences. She has worked for Ecolab for several years and has held various roles within the technical consulting team. She currently leads the European Technical Consulting Team. Her team are responsible for delivery of technical consulting in the areas of Cleanroom cleaning & disinfection, Cleaning in Place (CIP) and Hydrogen Peroxide Vapour (HPV) Bio-decontamination. Her team support clients in several areas such as review of existing regimes in line with regulatory expectation, troubleshooting specific issues, corrective and preventative actions, validation and general technical enquiries. Laura routinely presents on contamination control topics at industry seminars across the world.

  • Panelist: Tracy Moore, Director, TM Pharma Group Ltd

    

    Tracy Moore, Director, TM Pharma Group Ltd
    

    Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

  • Panelist: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

    

    Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
    

    Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

Breakout Session 5

Heather Suite A

Networking Lunch Break, Poster Session & Exhibition

Heather Suite B & Foyer

P7: EM & Airflow Visualization

Heather Suite A

• Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

  

  Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
  

  Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US. Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

• 13:10 – 13:30

  Environmental and Process Monitoring

  • Presenter: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK

    

    Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
    

    Kurt Jaecques is the Global Aseptic Technologies lead for Monitoring and Control at GSK and has been working within the pharmaceutical Industry for more than 30 years. He holds a Master's degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring, Bioburden Controlled Manufacturing and clean Utilities in particular. He co-chaired the update of the PDA TR13 on Environmental Monitoring and is PDA IG co-lead for Microbiology and Environmental Monitoring.

• 13:30 – 13:50

  Airflow Visualization

  • Presenter: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Cell & Gene Therapy, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

• 13:50 – 14:10

  Ensuring Excellence: Aseptic Process Simulation and EU GMP Annex 1 Compliance

  • Presenter: Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS

    

    Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS
    

    With 28 years of experience in sterile manufacturing, Maria has held various pivotal roles, in operations, aseptic lead, and technical operations lead for a recent high-potency facility startup. She has been instrumental in numerous startup facilities, guiding them from greenfield projects to full-scale commercial manufacturing. Currently, Maria serves in a global aseptic microbial SME for ExM and Internal sites, leveraging her extensive expertise to ensure the highest standards of aseptic processing and microbial control. Maria is also the founder and chair of the Ireland Sterile Manufacturing Community of Practice (COP). What began with just two sites has now grown to include over 40 sites, reflecting her commitment to fostering collaboration and excellence within the industry.

• 14:10 – 14:25

  Q&A

  • Moderator: Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech

    

    Francesco Cicirello, PharmD, MSc, Senior Director Global BioNTainer Quality Compliance, BioNTech
    

    Francesco Cicirello is Senior Director, Global BioNTainer Quality Compliance at BioNTech US. Before joining BioNTech from Evelo Biosciences and Adaptimmune , Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. While at TGA, he was elected to several roles in PIC/S. He was the Chairperson of the Working Group revising the Annex 2 and the Deputy Chair of the Subcommittee on Harmonisation. The latter role included overseeing the revision of the EU/WHO/PIC/S Annex 1. Francesco initiated the PIC/S transposition of EU Annex 16 and supported the one of Annex 13. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.

  • Panelist: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK

    

    Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK
    

    Kurt Jaecques is the Global Aseptic Technologies lead for Monitoring and Control at GSK and has been working within the pharmaceutical Industry for more than 30 years. He holds a Master's degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring, Bioburden Controlled Manufacturing and clean Utilities in particular. He co-chaired the update of the PDA TR13 on Environmental Monitoring and is PDA IG co-lead for Microbiology and Environmental Monitoring.

  • Panelist: Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland

    

    Patrick Nieuwenhuizen, MSc, Director Principal Consultant, PharmaLex Ireland
    

    Director Principal Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked in various Quality roles for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Cell & Gene Therapy, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance and New Facility Design/Upgrade. Risk facilitator for Quality Risk Management programs and gained significant experience with problem-solving and management of complex investigations. Co- author of the PDA Technical Report# 90 for “Contamination Control Strategy” and Edufarma’s education program “Farmaceutisch Vakman (Pharmaceutical Professional). Patrick holds a Master Degee in Pharmaceutical Microbiology form the University of Manchester.

  • Panelist: Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS

    

    Maria Ginnelly, MA, Principal Scientist, Aseptic Process Control Sciences, BMS
    

    With 28 years of experience in sterile manufacturing, Maria has held various pivotal roles, in operations, aseptic lead, and technical operations lead for a recent high-potency facility startup. She has been instrumental in numerous startup facilities, guiding them from greenfield projects to full-scale commercial manufacturing. Currently, Maria serves in a global aseptic microbial SME for ExM and Internal sites, leveraging her extensive expertise to ensure the highest standards of aseptic processing and microbial control. Maria is also the founder and chair of the Ireland Sterile Manufacturing Community of Practice (COP). What began with just two sites has now grown to include over 40 sites, reflecting her commitment to fostering collaboration and excellence within the industry.

Breakout Session 6

Heather Suite A

Networking Coffee Break, Poster Session & Exhibition

Heather Suite B & Foyer

Passport Raffle

Heather Suite A

P8: Contamination Control Strategy

Heather Suite A

• Moderator: Tracy Moore, Director, TM Pharma Group Ltd

  

  Tracy Moore, Director, TM Pharma Group Ltd
  

  Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

• 15:45 – 16:05

  Contamination Control Strategy Management

  • Presenter: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    

    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at  amcfarland@valsource.com.

• 16:05 – 16:45

  Plenary Discussion

  • Moderator: Tracy Moore, Director, TM Pharma Group Ltd

    

    Tracy Moore, Director, TM Pharma Group Ltd
    

    Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

  • Panelist: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    

    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and co-lead of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at  amcfarland@valsource.com.

  • Regulatory Panelist: Thomas Vestergaard Pedersen

    

    Thomas Vestergaard Pedersen
    

  • Regulatory Panelist: Aedin Hogan

    

    Aedin Hogan
    

Day 2 Report Out & Closing Remarks from the Workshop Co-Chairs

Heather Suite A

• Co-Chair: Tracy Moore, Director, TM Pharma Group Ltd

  

  Tracy Moore, Director, TM Pharma Group Ltd
  

  Tracy Moore is an accomplished quality professional with over 35 years of experience in pharmaceutical manufacture, distribution and regulation gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA), where she reached Expert Inspector level/status. During her ten years as a GMP Inspector, Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy was a drafting member of the MHRA EU PICS GMP Annex 1 document in addition to Annex 16 and Annex 21 and the MHRA GXP data Integrity lead, publishing the 2018 guidance document. Tracy set up the MHRA's inspector academy in 2020, which allowed for an efficient accreditation of MHRA inspectors and assessed Member States ' inspectors' competence through the Joint Audit Programme for EU. Before MHRA, Tracy spent 22 years working in the pharmaceutical industry's commercial and R&D environments in QA, QP and management roles covering sterile and non-sterile product dosage forms, including biologics and oral vaccines.

• Co-Chair: Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.

  

  Frederic B. Ayers, Senior Consultant - Microbiology, ValSource, Inc.
  

  Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.

Closing Remarks & Farewell

Heather Suite A

• Committee Member: Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association

  

  Falk Klar, PhD, General Manager, Vice President Europe, 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.