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2021 Annex1_1988x680

2021 PDA Annex 1 Conference

Practical Solutions for the New Annex 1 Implementation - Prepare for Change Now

Jun 08 - Jun 09, 2021
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Europe

Overview

Dear Colleagues,

On behalf of the Scientific Program Planning Committee and PDA Europe, we are proud to present the 2021 PDA Annex 1 Conference to take place on 8-9 June 2021!

The long-awaited draft of the revised Annex 1 was released for discussion last year and now the final revision is anticipated later this year. The document’s focus and content has changed significantly, and the industry is eager to see how these changes will result in new requirements, inspection expectations, and overall process control strategies. Clarification on the intent of new and existing requirements is anticipated.

This conference will cover the impact on the industry and on manufactures. Local authorities and industry speakers representing medicines and vaccines manufacturers, as well as equipment and instrumentation suppliers, will present their views on the revised Annex 1 and the modifications it induces. Sufficient time has been allocated to discuss how to address the new requirements and be proactive in getting ready to comply with the new regulation.

The conference will feature experts from all over the world and will provide plenty of opportunity for interaction between attendees, the speakers, and the program committee members during live Q&A sessions.

We look forward to you joining us in June!

Sincerely,

The Chairs

Gabriele Gori, GSK
Hal Baseman, ValSource

SCIENTIFIC PROGRAM PLANNING COMMITTEE

Gabriele Gori, GSK Vaccines, Chair
Hal Baseman, ValSource, Chair
Darren Beckett, Sterility Solutions
John Henchion, CAI
Andrew Hopkins, AbbVie
Brid Lynch, Janssen J&J
Janie Miller, PDA
Falk Klar, PDA Europe
Sylvia Becker, PDA Europe, Senior Manager Programs & Events

Agenda

  • Day 1
  • Day 2
  • Tuesday, 8 June 2021

    Module I: Welcome & Annex 1 Revision Regulatory Perspectives & Updates
    11:00-14:15 CEST

    Conference Portal Opens: Please Create Your User Profile!

    Welcome & Introductions Falk Klar, PDA Europe
    Welcome from the Chairs Gabriele Gori, GSK
    Hal Baseman, ValSource

    Opening Plenary:
    Annex 1 Revision Regulatory Perspectives & Updates

    Moderators:
    Gabriele Gori, GSK
    Hal Baseman, ValSource

    Regulatory Perspective on the Role of Annex 1 Tracy Moore, MHRA
    Understanding and Implementing Annex 1 Changes Hal Baseman, ValSource
    Industry Perspective, Challenges in the Industry due to COVID/Brexit Andrew Hopkins, AbbVie

    Live Q & A, Discussion


    Lunch Break 

    14:15-15:15 CEST

    Module II: Developing Effective Contamination Control Strategies
    15:15-17:00 CEST

    Live Session Introduction:
    Developing Effective Contamination Control Strategies

    Moderators:
    Brid Lynch, Janssen J&J
    John Henchion, CAI

    New PDA Technical Report on Contamination Control Strategy Cheryl Essex, Sanofi, on behalf of the PDA Task Force
    Contamination Control Strategy – From Annex 1 Draft Requirements to Implementation in Practice Helen Sauter, Vetter
    Microbiological Quality Control Strategy (MQCS) Dieter Bachmann, Janssen J&J

    Live Q & A, Panel Discussion

    Agenda is subject to change without notice.

     

    Virtual Networking Lounge - Virtual Reality by Innerspace
    17:00-18:00 CEST

    Opportunities and Limitations for Using Simulators in Virtual Reality to Help Meet New Annex 1 Regulatory Requirements

    Moderator:
    Falk Klar, PDA Europe 
    Speakers:
    Sebastian Scheler, Innerspace, 
    Alexander Stoll, Fresenius Kabi,
    Dieter Bachmann, Janssen J&J

    Annex 1 serves as a guideline for sterile medicinal products, in the new version high requirements for personnel and their behavior are expected. Simulators in virtual reality seem to be very suitable for meeting these requirements since mission-critical behavior can be trained effectively, and precise behavior measurement and standardized success control are possible.

  • Wednesday, 9 June 2021

    Module III: Aseptic Process - Control and Monitoring
    9:00-12:00 CEST

    Conference Portal Opens

    Live Session Introduction:
    Aseptic Process - Control and Monitoring

    Moderators:
    Gabriele Gori, GSK
    Andrew Hopkins, AbbVie

    Aseptic Process Validation Marcia Baroni, Emergent BioSolutions
    New Requirements of the revised Annex 1 for Clean Room Qualification and Monitoring Jette Christensen, Novo Nordisk
    An Effective Cleaning Strategy for the Equipment that Will Be Installed Inside a Filling Line; Examples of Contamination Control Maria Luisa Bernuzzi 

    Alessia CinaFedegari Autoclavi

    Continuous Microbial Air Monitoring Eric Clement Arakel, Sartorius

    Live Q & A, Discussion


    Lunch Break

    12:00-13:00 CEST

    Module IV: Technology and Manufacturing Systems
    13:00-15:15 CEST

    Live Session Introduction:
    Technology and Manufacturing Systems

    Moderators:
    Gabriele Gori, GSK
    Hal Baseman, ValSource

    Summary of Day 1 Gabriele Gori, GSK
    Technology Considerations in Annex 1 Hal Baseman, ValSource
    Barrier Technology Control Christophe Haentzler, GSK
    Isolators & PDA ISO Points to Consider Guenther Gapp, GappQuality
    How to Apply Annex 1 Requirements for Fully Automated Robotic Fill and Finish System Richard Denk, SKAN
    Bianca Bohrer, Topmedicare 

     

    Live Q & A, Panel Discussion


    Coffee Break

    15:15-15:35 CEST

    Module V: Sterility Assurance Control Measures
    15:35-18:00 CEST

    Live Session Introduction:
    Sterility Assurance Control Measures

    Moderators:
    Darren Beckett, Sterility Solutions
    Brid Lynch, Janssen J&J

    Sterile Filtration: PUPSIT and SFQRM (sterile filtration quality risk management) Update Maik Jornitz, G-CON Manufacturing 
    Sterile Grade Filtration: A Regulatory Overview and Process Applications in Light of New Expectations from Annex 1 Revision Antonio Filippo Legnani, DOC
    CCIT and CCIT Challenges to Comply with the Revised Annex 1 Alexander Stoll, Fresenius Kabi
    Positive Controls for Container Closure Integrity Testing (CCIT), an Integrated Approach and Recent Advancements Chris Randon, OpTek Systems

    Closing Panel Discussion: Future Outlook

    Conference Summary by the Chairs

    Gabriele Gori, GSK
    Hal Baseman, ValSource

    Thank you, Chair Awards, Outlook and Farewell

    Falk Klar, PDA Europe
    Agenda is subject to change without notice.

Registration Fees

Register Now
Registration Type Price after 11 APR 2021
Member €1.595
Non-Member €1.895
Govern./Health Authority/Academic/
Young Professional (Member)
€600

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