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PDA Annex 1 Workshop 2024
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Call for Posters
By submitting your scientific poster you will join our poster presentation and gain more visibility.
Deadline: 20 September 2024
Learn More Poster SubmissionsDear Colleagues,
The PDA is delighted to announce the return of our esteemed event, the PDA Annex 1 Workshop 2024, scheduled to take place on 05-06 November 2024, in the vibrant city of Dublin, Ireland.
This workshop is designed to educate and support the industry in adapting to the revised EU GMP Annex 1. At PDA, we remain steadfast in our commitment to providing scientifically rigorous, practical, and technical information, along with training programs that contribute to the advancement of science and regulation for both our members and the broader industry.
Workshop Objectives:
Address Challenges: The primary goal of the workshop is to tackle the challenges and implications associated with the revised EU GMP Annex 1.Critical Changes: We will delve into specific sections, ensuring attendees gain a comprehensive understanding of how to successfully navigate the requirements of the updated Annex.
Engage and Learn: Attendees will have the invaluable opportunity to hear insights from industry experts and regulators, and interactive sessions will foster open discussions among peers, allowing for the sharing of challenges and best practices.
Standardized Approach: PDA has established a standardized approach to workshop topics, ensuring that the information disseminated to the industry remains consistent and pertinent to the current regulatory landscape.
We eagerly anticipate welcoming you to this enriching event!
Sincerely,
The Co-Chairs
Fred Ayers, ValSource
Tracy Moore, TM Pharma Group
SCIENTIFIC PROGRAM PLANNING COMMITTEE:
- Fred Ayers, ValSource
- Tracy Moore, TM Pharma Group
- Marcia Baroni, EBSI
- Laura Brennan, Ecolab
- Francesco Cicirello, BioNTech
- Richard Denk, SKAN
- Derek Duncan, LIGHTHOUSE Instruments
- Maria Ginnelly, BMS
- Kurt Jaecques, GSK
- Amanda McFarland, ValSource
- Patrick Nieuwenhuizen, PharmaLex
- Jessie Lindner, PDA
- Falk Klar, PDA Europe
- Sabine Hartmann, Manager Programs & Events, PDA Europe
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Early Registration
Register by 08 September 2024
Member Price
€ 2.050GovernmentMember Only
€ 980
Health AuthorityMember Only
€ 980
Early Career ProfessionalMember Only
€ 980
StudentMember Only
€ 980
AcademicMember Only
€ 980
Non-Member
€ 2.350
Standard Registration
Register after 08 September 2024
Member Price
€ 2.250GovernmentMember Only
€ 1.080
Health AuthorityMember Only
€ 1.080
Early Career ProfessionalMember Only
€ 1.080
StudentMember Only
€ 1.080
AcademicMember Only
€ 1.080
Non-Member
€ 2.550
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Tuesday, 5 November GMT
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Registration Open
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Welcoming
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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.
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Welcome Remarks from Workshop Co-Chairs
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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.
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P1: EU GMP Annex 1 Implementation – A Regulator’s Perspective
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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.
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Networking Coffee Break, Poster Session & Exhibition
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P2: Quality Risk Management & Knowledge Management
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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.
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EU GMP Annex 1 and Quality Risk Management
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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.
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Knowledge Management in Pharmaceutical Manufacturing
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Presenter: Melanie Adams
Melanie Adams
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Q&A
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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 Adams
Melanie Adams
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Breakout Session 1
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Networking Lunch Break, Poster Session & Exhibition
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P3: Cleanroom Design & Barrier System Integration
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Moderator: 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.
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Cleanroom Design
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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.
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Barrier Systems
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Presenter: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.
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Q&A
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Moderator: 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. -
Panelist: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.
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Breakout Session 2
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Networking Coffee Break, Poster Session & Exhibition
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P4: Decontamination & Material Transfer
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Moderator: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.
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Material Transfer - overcoming the challenge.
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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.
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CCS on Indirect Product Contact Surfaces - Transfer and Assembly
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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.
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Q&A
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Moderator: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University. -
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.
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Breakout Session 3
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Day 1 Wrap Up
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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.
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Wednesday, 6 November GMT
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Networking Reception
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Registration Open
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P5: Personnel
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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.
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Training & Qualification
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Presenter: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University.
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Gowning & Personnel Monitoring
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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, 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.
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Q&A
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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: Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
Marcia C. Baroni, MBA, VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University. -
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, 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.
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Breakout Session 4
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Networking Coffee Break, Poster Session & Exhibition
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P6: Aseptic Processing & Pre-Use Post Sterilization Integrity Testing (PUPSIT)
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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.
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Aseptic Processing 1
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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.
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Aseptic Processing 2
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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.
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Q&A
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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.
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Breakout Session 5
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Networking Lunch Break, Poster Session & Exhibition
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P7: EM & Airflow Visualization
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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.
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Environmental and Process Monitoring
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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.
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Airflow Visualization
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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, 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.
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Aseptic Process Simulation
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Presenter: Maria Ginnelly
Maria Ginnelly
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Q&A
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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, 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
Maria Ginnelly
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Breakout Session 6
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Networking Coffee Break, Poster Session & Exhibition
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Passport Raffle
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P8: Contamination Control Strategy
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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.
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Contamination Control Strategy
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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.
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Plenary Discussion
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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
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Regulatory Panelist: Aedin Hogan
Aedin Hogan
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Day 2 Report Out & Closing Remarks from the Workshop Co-Chairs
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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.
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Closing Remarks & Farewell
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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.
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Presenters
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Melanie Adams
Panelist
Presenter
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Frederic B. Ayers
Senior Consultant - Microbiology, ValSource, Inc.
Co-Chair
Moderator
Panelist
Presenter
Read BioFrederic B. Ayers
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. -
Marcia C. Baroni, MBA
VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions
Moderator
Panelist
Presenter
Read BioMarcia C. Baroni, MBA
Emergent BioSolutions
With over 25 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality, Enterprise GxP Compliance & Systems for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for GxP Compliance and Global Quality Systems across Emergent's organization. Marcia is a Microbiologist from the University of Toronto and holds an MBA from Purdue University. -
Laura Brennan
Director of Technical Consulting, Ecolab
Moderator
Panelist
Presenter
Read BioLaura Brennan
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. -
Francesco Cicirello, PharmD, MSc
Senior Director Global BioNTainer Quality Compliance, BioNTech
Moderator
Read BioFrancesco Cicirello, PharmD, MSc
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. -
Richard Denk
Senior Consulting Aseptic Processing & Containment, SKAN AG
Moderator
Panelist
Presenter
Read BioRichard Denk
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. -
Maria Ginnelly
Panelist
Presenter
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Aedin Hogan
Regulatory Panelist
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Kurt Jaecques, MA
Global Aseptic Technologies Lead Monitoring & Control, GSK
Moderator
Panelist
Presenter
Read BioKurt Jaecques, MA
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. -
Falk Klar, PhD
Parenteral Drug Association
Committee Member
Read BioFalk 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. -
Amanda McFarland, MS
Senior Consultant, ValSource, Inc.
Panelist
Presenter
Read BioAmanda McFarland, MS
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. -
Tracy Moore
Director, TM Pharma Group Ltd
Co-Chair
Moderator
Panelist
Presenter
Read BioTracy Moore
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. -
Patrick Nieuwenhuizen, MSc
Director Principal Consultant, PharmaLex Ireland
Panelist
Presenter
Read BioPatrick Nieuwenhuizen, MSc
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, 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. -
Thomas Vestergaard Pedersen
Regulatory Panelist
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