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P1: Overview of and Revision Process for Annex 1
Bruce Loxley (Co-Chair)•Lisa Bennett (Co-Chair)

Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. The revised Annex 1 contains a significant amount of new and more detailed content on many topics. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes.

  • Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

    Bruce Loxley (Co-Chair)

    Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
Welcome Remarks from Workshop Co-Chairs
Bruce Loxley (Co-Chair)•Lisa Bennett (Co-Chair)
  • Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

    Bruce Loxley (Co-Chair)

    Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
Revision of Annex 1
Matthew Davis (Virtual)
  • Matthew Davis (Virtual) (Inspections Team Lead & Senior Inspector Manufacturing Quality Branch at Therapeutic Goods Administration)

    Matthew Davis (Virtual)

    Inspections Team Lead & Senior Inspector Manufacturing Quality Branch at Therapeutic Goods Administration
Insights from a Former Regulator
Andrew Hopkins
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
Insights from a Former Regulator
Zhihao Peter Qiu
  • Zhihao Peter Qiu (External Advocacy Lead China, Global Quality and Compliance at Roche Genentech)

    Zhihao Peter Qiu

    External Advocacy Lead China, Global Quality and Compliance at Roche Genentech
Panel Discussion and Q&A
Matthew Davis (Virtual)•Meow Hoe Boon•Andrew Hopkins•Zhihao Peter Qiu•Bruce Loxley (Co-Chair)•Lisa Bennett (Co-Chair)
  • Matthew Davis (Virtual) (Inspections Team Lead & Senior Inspector Manufacturing Quality Branch at Therapeutic Goods Administration)

    Matthew Davis (Virtual)

    Inspections Team Lead & Senior Inspector Manufacturing Quality Branch at Therapeutic Goods Administration
  • Meow Hoe Boon (Deputy Director - OA of Health Sciences Authority)

    Meow Hoe Boon

    Deputy Director - OA of Health Sciences Authority
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
  • Zhihao Peter Qiu (External Advocacy Lead China, Global Quality and Compliance at Roche Genentech)

    Zhihao Peter Qiu

    External Advocacy Lead China, Global Quality and Compliance at Roche Genentech
  • Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

    Bruce Loxley (Co-Chair)

    Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
Coffee Break at the Exhibit Area
P2: Scope, Principles and Pharmaceutical Quality Systems
Emily Cheah

This session opens our in-depth look at the content of the draft Annex 1. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. This session will also address the expanded scope of Annex 1 to include some non-steriles.

  • Emily Cheah (Senior Managing Director of Charles River Laboratories)

    Emily Cheah

    Senior Managing Director of Charles River Laboratories
Using Quality Risk Management to Enable the Contamination Control Strategy
James Vesper
  • James Vesper (Director of Valsource)

    James Vesper

    Director of Valsource
Considerations of Annex 1 for Advanced Therapy Medicinal Products
Francesco Cicirello (Virtual)
  • Francesco Cicirello (Virtual) (Senior Director, Quality Assurance of Evelo Biosciences)

    Francesco Cicirello (Virtual)

    Senior Director, Quality Assurance of Evelo Biosciences
Lunch Break
Product Demo by Datwyler: MINIMIZING POTENTIAL RISKS OF PRIMARY PACKAGING FOR A SUCCESSFUL BIOTECH DRUG DEVELOPMENT
Wilson Mizoguchi
  • Wilson Mizoguchi (Head of Market Development, SEA at Datwyler Healthcare)

    Wilson Mizoguchi

    Head of Market Development, SEA at Datwyler Healthcare
Breakout Session for P1 • Overview of and Revision Process for Annex 1 and P2 • Scope, Principles and Pharmaceutical Quality Systems

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems.

Q&A for P2: Scope, Principles and Pharmaceutical Quality Systems
Emily Cheah•Francesco Cicirello (Virtual)•James Vesper•Lisa Bennett (Co-Chair)
  • Emily Cheah (Senior Managing Director of Charles River Laboratories)

    Emily Cheah

    Senior Managing Director of Charles River Laboratories
  • Francesco Cicirello (Virtual) (Senior Director, Quality Assurance of Evelo Biosciences)

    Francesco Cicirello (Virtual)

    Senior Director, Quality Assurance of Evelo Biosciences
  • James Vesper (Director of Valsource)

    James Vesper

    Director of Valsource
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
P3: Premises and Barrier Systems
Catherine Thomson

Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1.

  • Catherine Thomson (Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence)

    Catherine Thomson

    Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence
Cleanroom Design: Classification, Qualification, Air Visualization
Andrew Hopkins
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
Matthew Cokely
  • Matthew Cokely (Global Technical Consultant Regional Leader at Ecolab)

    Matthew Cokely

    Global Technical Consultant Regional Leader at Ecolab
Coffee Break at the Exhibit Area
Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
Richard Denk
  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG
Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces
Richard Denk
  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG
Steam Sterilization and Transfer of Parts into the Isolator/ RABS
Renee Buthe (Virtual)
  • Renee Buthe (Virtual) (Technical Services Specialist at STERIS)

    Renee Buthe (Virtual)

    Technical Services Specialist at STERIS
Break-out Session for P3 • Premises and Barrier Systems

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems.

Q&A for P3 • Premises and Barrier Systems
Renee Buthe (Virtual)•Matthew Cokely•Richard Denk•Andrew Hopkins•Catherine Thomson•Emily Cheah
  • Renee Buthe (Virtual) (Technical Services Specialist at STERIS)

    Renee Buthe (Virtual)

    Technical Services Specialist at STERIS
  • Matthew Cokely (Global Technical Consultant Regional Leader at Ecolab)

    Matthew Cokely

    Global Technical Consultant Regional Leader at Ecolab
  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
  • Catherine Thomson (Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence)

    Catherine Thomson

    Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence
  • Emily Cheah (Senior Managing Director of Charles River Laboratories)

    Emily Cheah

    Senior Managing Director of Charles River Laboratories
Networking Reception
Registration
Day 1 Report Out
Bruce Loxley (Co-Chair)•Lisa Bennett (Co-Chair)
  • Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

    Bruce Loxley (Co-Chair)

    Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
P4: TR90 • Contamination Control Strategy Development
Dinesh Khokal

In this session, the presenters will review PDA’s approach to the development of a CCS. Using case studies, discussions will focus on how to identify contamination risks, embed quality risk management (QRM) risk principles, and implement appropriate controls.

  • Dinesh Khokal (Director and Regional Lead, External Affairs, JAPAC of Amgen)

    Dinesh Khokal

    Director and Regional Lead, External Affairs, JAPAC of Amgen
Introduction to CCS Development & a Case Study
Cheryl Essex (Virtual)
  • Cheryl Essex (Virtual) (Head of Quality Operations R&D Genomic Medicine Unit at Sanofi)

    Cheryl Essex (Virtual)

    Head of Quality Operations R&D Genomic Medicine Unit at Sanofi
Considerations of Annex 1 for Low Bioburden Products
Francesco Cicirello (Virtual)
  • Francesco Cicirello (Virtual) (Senior Director, Quality Assurance of Evelo Biosciences)

    Francesco Cicirello (Virtual)

    Senior Director, Quality Assurance of Evelo Biosciences
Contamination Control Strategy Implementation Case Study
Catherine Thomson
  • Catherine Thomson (Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence)

    Catherine Thomson

    Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence
Coffee Break at the Exhibition Area
Breakout Session for P4: TR90 • Contamination Control Strategy Development
Q&A for P4: TR90 • Contamination Control Strategy Development
Francesco Cicirello (Virtual)•Cheryl Essex (Virtual)•Dinesh Khokal•Catherine Thomson•Bruce Loxley (Co-Chair)
  • Francesco Cicirello (Virtual) (Senior Director, Quality Assurance of Evelo Biosciences)

    Francesco Cicirello (Virtual)

    Senior Director, Quality Assurance of Evelo Biosciences
  • Cheryl Essex (Virtual) (Head of Quality Operations R&D Genomic Medicine Unit at Sanofi)

    Cheryl Essex (Virtual)

    Head of Quality Operations R&D Genomic Medicine Unit at Sanofi
  • Dinesh Khokal (Director and Regional Lead, External Affairs, JAPAC of Amgen)

    Dinesh Khokal

    Director and Regional Lead, External Affairs, JAPAC of Amgen
  • Catherine Thomson (Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence)

    Catherine Thomson

    Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence
  • Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

    Bruce Loxley (Co-Chair)

    Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK
P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
Andrew Hopkins

Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy.

  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
Qualification and Training | QRM & PQS as foundations to CCS
James Vesper
  • James Vesper (Director of Valsource)

    James Vesper

    Director of Valsource
Gowning, Personnel Monitoring, and Beyond
Ivy Louis
  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting
Break-out Session for P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment.

Q&A for P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
Andrew Hopkins•Ivy Louis•James Vesper•Lisa Bennett (Co-Chair)
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting
  • James Vesper (Director of Valsource)

    James Vesper

    Director of Valsource
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
Lunch
P6: Production Technologies
Ivy Louis

This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success.

  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting
Aseptic Processing
Zhihao Peter Qiu
  • Zhihao Peter Qiu (External Advocacy Lead China, Global Quality and Compliance at Roche Genentech)

    Zhihao Peter Qiu

    External Advocacy Lead China, Global Quality and Compliance at Roche Genentech
Container Closure Integrity Testing and Finishing
Derek Duncan•Michael Edey
  • Derek Duncan (Director of Product Line at LIGHTHOUSE)

    Derek Duncan

    Director of Product Line at LIGHTHOUSE
  • Michael Edey (Senior Principal Engineer at Pfizer)

    Michael Edey

    Senior Principal Engineer at Pfizer
Filtration and Pre-Use Post Sterilization Integrity Testing
Wayne Lee
  • Wayne Lee (Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation)

    Wayne Lee

    Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation
Break-out Session for P6: Production Technologies

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing).

Q&A for P6: Production Technologies
Derek Duncan•Michael Edey•Wayne Lee•Ivy Louis•Zhihao Peter Qiu•Emily Cheah
  • Derek Duncan (Director of Product Line at LIGHTHOUSE)

    Derek Duncan

    Director of Product Line at LIGHTHOUSE
  • Michael Edey (Senior Principal Engineer at Pfizer)

    Michael Edey

    Senior Principal Engineer at Pfizer
  • Wayne Lee (Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation)

    Wayne Lee

    Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation
  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting
  • Zhihao Peter Qiu (External Advocacy Lead China, Global Quality and Compliance at Roche Genentech)

    Zhihao Peter Qiu

    External Advocacy Lead China, Global Quality and Compliance at Roche Genentech
  • Emily Cheah (Senior Managing Director of Charles River Laboratories)

    Emily Cheah

    Senior Managing Director of Charles River Laboratories
Coffee Break in Exhibition Area
P7: Aseptic Process Simulation and Environmental Monitoring
Emily Cheah

Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process.

  • Emily Cheah (Senior Managing Director of Charles River Laboratories)

    Emily Cheah

    Senior Managing Director of Charles River Laboratories
Aseptic Process Simulation
Andrew Hopkins
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
Environmental and Process Monitoring
Ivy Louis
  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting
Q&A for P7: Aseptic Process Simulation and Environmental Monitoring
Emily Cheah•Andrew Hopkins•Ivy Louis•James Vesper
  • Emily Cheah (Senior Managing Director of Charles River Laboratories)

    Emily Cheah

    Senior Managing Director of Charles River Laboratories
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie
  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting
  • James Vesper (Director of Valsource)

    James Vesper

    Director of Valsource
Day 2 Report out
Lisa Bennett (Co-Chair)•Bruce Loxley (Co-Chair)
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
  • Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

    Bruce Loxley (Co-Chair)

    Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK
Closing Remarks
Lisa Bennett (Co-Chair)•Bruce Loxley (Co-Chair)
  • Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

    Lisa Bennett (Co-Chair)

    Senior GMP Consultant and Trainer at SeerPharma
  • Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

    Bruce Loxley (Co-Chair)

    Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK