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!
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
Discover What's Happening Each Day
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: |
Moderators: |
| 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: |
Moderators: |
| 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 |
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Live Q & A, Panel Discussion |
Virtual Networking Lounge - Virtual Reality by Innerspace
17:00-18:00 CEST
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Opportunities and Limitations for Using Simulators in Virtual Reality to Help Meet New Annex 1 Regulatory Requirements |
Wednesday, 9 June 2021
Module III: Aseptic Process - Control and Monitoring
9:00-12:00 CEST
Conference Portal Opens
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Live Session Introduction: |
Moderators: |
| 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 Cina, Fedegari Autoclavi |
| Continuous Microbial Air Monitoring | Eric Clement Arakel, Sartorius |
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Live Q & A, Discussion |
Lunch Break
12:00-13:00 CEST
Module IV: Technology and Manufacturing Systems
13:00-15:15 CEST
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Live Session Introduction: |
Moderators: |
| 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
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Live Q & A, Panel Discussion |
Coffee Break
15:15-15:35 CEST
Module V: Sterility Assurance Control Measures
15:35-18:00 CEST
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Live Session Introduction: |
Moderators: |
| 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 |
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Closing Panel Discussion: Future Outlook |
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Conference Summary by the Chairs |
Gabriele Gori, GSK Hal Baseman, ValSource |
|
Thank you, Chair Awards, Outlook and Farewell |
Falk Klar, PDA Europe |
Registration
Pricing Options
Standard Registration
Member Price
€1.595Non-Member
€1.895
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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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