2021 PDA Annex 1 Conference

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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

Standard Pricing

Standard Member Price

€1.595

Non-Member

€1.895

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

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 [email protected] 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.

Day 1

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.

Day 2

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.

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