2023 PDA Good Aseptic Manufacturing Conference
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Program Highlights
Check out the agenda below and look forward to presentations from regulators such as Christina Meissner, Austrian Agency for Health and Food Safety and Sandra Boyd, U.S. FDA.
Dear Colleague,
The new EU GMP Annex 1 is officially published and will take effect in August 2023.
Are you curious to learn about how your peers are approaching those new challenges, adopting new methods, and dealing with innovant technologies?
If so, we invite you to the 2023 PDA Good Aseptic Manufacturing Conference which will take place on 23 – 24 May 2023 in Leipzig, Germany.
This first edition will be accompanied by a site visit at IDT Biologika in Dessau on 25 May 2023, where you can experience how it works out in practice.
Planned to be held annually traveling around Europe, subsequent conference editions will offer the opportunity to have site visits at other CDMOs, vendors, or pharma companies contributing/active in aseptic manufacturing.
We are convinced this will be a great occasion to share efficient solutions in implementing the requirements of EU GMP Annex 1, including new methods, innovation tools, and developments covering new technologies, equipment, and utilities.
The conference will be a great opportunity by bringing together manufacturers, regulators, and experts, to highlight solutions that will significantly contribute to the body of knowledge relating to aseptic manufacturing.
To that end, PDA has designed a conference that provides an interactive forum to discuss, debate, and learn about the trends and strategies to take those challenges.
This is a unique opportunity, which you should not afford to miss.
Looking forward to seeing you in Leipzig!
Sincerely,
The Chairs
Kerstin Wilken, IDT Biologika
Paul Devuyst, GSK
SCIENTIFIC PROGRAM PLANNING COMMITTEE:
- Kerstin Wilken, IDT Biologika
- Paul Devuyst, GSK
- Darren Beckett, Fedegari
- Simone Biel, Merck KGaA
- Richard Denk, SKAN
- Rainer Glöckler, ten23 heath
- Gabriele Gori, Zambon
- Rob Hendrix, Janssen Pharma
- David Keen, Ecolab
- Arne Kloke, Alliance to Zero on behalf of SCHOTT Pharma
- Peter Makowenskyj, GCon Bio
- Tracy Moore, TM Pharma Group
- Davor Pavetic, Sandoz
- Andrea Salmaso, Stevanato Group
- Helen Sauter, Vetter Pharma
- Carrie Horton, PDA
- Falk Klar, PDA Europe
- Caroline Lynar, Manager Programs & Events, PDA Europe
Agenda
Discover What's Happening Each Day
Tuesday, 23 May 2023
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09:00 Welcome and Introduction |
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09:15 - 12:40 I Opening Plenary: Regulatory and Industry Updates Besides general points to consider for the implementation of the new EU GMP Annex 1, rapid microbiological methods and the transfer of people and material will be the focus of this session. We will hear the view from authorities and industry. Also, the impact of aseptic fill & finish, on the manufacturer and user will be presented and discussed. |
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09:15 I Keynote: Points-to-Consider Implementing EU GMP Annex 1 |
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09:45 I Rapid Microbiological Methods in the Light of EU GMP Annex 1 |
10:15 - 10:45 | Coffee Break, Poster Session & Exhibition
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10:45 I Transfer of People and Materials 11:15 I Impact on the Filling Machine, Manufacturer, and User |
12:40 - 14:00 | Lunch Break, Guided Poster Session & Exhibition
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14:00 - 15:20 I Session 1 Track A: Barrier Systems Barrier Systems are mentioned 15 times in the EU GMP Annex 1 and any alternative use should be justified. Closed RABS or Isolators are the recommended technologies as well as fully gloveless robotic aseptic filling lines. The first Robotic Award-Winning Solution will be presented from Novartis together with Groninger. What other challenges are addressed with new technologies in accordance with the new Annex 1 will be presented in this session from PM Group. |
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14:00 I Gloveless Robotic Filling Line - How to Meet Regulatory and Industry Requirements 14:25 I Challenges for New Technologies in Sterile Medicinal Products - Outlined in the Revised Annex 1 Regulation 14:50 I Q&A, Discussion |
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14:00 - 15:20 I Session 1 Track B: Contamination Control Strategy During this session, the first presentation will provide guidance on implementing an effective Contamination Control Strategy (CCS) across an existing CDMO facility including best practices for robust sterility assurance. We'll also discuss during the second presentation, control elements to protect critical product contact surfaces and filling environments. End-user case studies will demonstrate successful CCS analysis and how to maintain sterility assurance and critical environment continuity. |
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14:00 I Contamination Control Strategy - From the Requirements of Annex 1 to Implementation 14:25 I Sterility Assurance and Contamination Control Strategies 14:50 I Q&A, Discussion |
15:20 - 15:50 | Coffee Break, Poster Session & Exhibition
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15:50 - 17:25 I Session 2 Track A: Aseptic Processing At the heart of patient safety, aseptic processing is a critical component of drug product manufacturing. What tools are available to properly assess risk in our processes and enable process improvement? Is all autoclave packaging created equal and what processes should we employ to confirm what is most suitable and compliant? What risks exist around integrity testing of sterile filters post sterilization and what are best considerations? These are just a handful of topics the presenters will discuss ensuring everyone will leave enlightened from their discussions. |
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15:50 I PDA ANSI Standard Approach to Quality Risk Management in Aseptic Processing 16:05 I Packaging Materials for Sterilization Process According to New Annex 1 16:30 I Implementation of PUPSIT to Compliment Annex 1 16:55 I Q&A, Discussion |
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15:50 - 17:25 I Session 2 Track B: Contamination Control Strategy – Focus Testing Training and qualification of personnel are fundamental controls, and it can also be of benefit during the design and development phases of an aseptic manufacturing process. This session will give some insights how training and qualification could be embedded throughout the entire process lifecycle, including the use of novel technologies. |
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15:50 I Development of a Holistic Aseptic Training Program – A Lifecycle Approach 16:05 I Fast Release of Sterile Primary Packaging Containers Using a Rapid Microbial Method: Case Study 16:30 I Moving Forward to Continuous and Real-time Environmental Monitoring for Aseptic Filling 16:55 I Q&A, Discussion |
17:25 | End of Conference Day 1 and Networking Event
Wednesday, 24 May 2023
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09:00 - 10:20 I Session 3: Operators, Training & Qualification Despite the advancement of the technology, personnel remain a key player for the efficient manufacturing of quality products. Proper training and qualification of new personnel, as well as keeping their knowledge and expertise updated in the shortest possible time is even more important in the modern fast-paced environment, where launching of new products and the prevention of mistakes to avoid delays and waste of resources are of outmost importance. |
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09:00 I Human Factor Control Strategy for Aseptic Manufacturing: Introducing a Frame-by-Frame Risk Profiling & Mitigation Approach 09:25 I Facilitating Short and Efficient Training Periods for New Personnel 09:50 Q&A, Discussion |
10:20 - 10:50 | Coffee Break, Poster Session & Exhibition
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10:50 - 12:10 I Session 4: Disinfection/Decontamination Cleaning, Disinfection and decontamination form a vital part of any sites Contamination Control Strategy, join us, and learn from experts, both users and suppliers of current best practise for implementation of these vital control points. |
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10:50 I Meeting the Challenges of Annex 1 with Innovation in Rapid H2O2 Validation 11:15 I Collaborating to Innovate Effective Disinfectant Rotation Strategies for Contamination Control 11:40 I Q&A, Discussion |
12:10- 13:10 | Lunch Break, Poster Session & Exhibition
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13:10 - 16:35 I Closing Plenary: Application of Aseptic Processing to Various Product Classes In this session, Speakers will share their recent shop floor experience. Learn more on how innovative developments could be the perfect answer and/or how to integrate Annex 1 prescriptions. Additionally, this session will illustrate the consequences of concepts up to the real implementation of a filling area for high potent drug substances. Look forward to collecting the inspector’s view and feedback related to material transfer from the Grade C/D environment to Grade A restricted Barriers. This closing session will also give the time to collect and summarize the lessons learned from these two conference days and give a first view of what will be seen during the site visit at IDT Biologika. |
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13:10 I Interactive Questionnaire Session 13:20 I Aseptic Processing for Advanced Therapies - From Manual to Fully Automated Fill & Finish 13:45 I Implementation of a New Aseptic Filling Area at Sanofi Frankfurt – A Reflection on the Impact of Annex 1 Revision |
14:10 - 14:40 | Coffee Break, Poster Session & Exhibition
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14:45 I U.S. FDA Expectations on Barrier Systems 15:10 I Biologics Manufacturing and Implementation of Annex 1 at IDT Biologika 15:35 I Closing Panel Discussion 16:15 I Chairs Conference Summary 16:30 I Closing Remarks & Farewell |
16:35 End of Conference
Agenda is subject to change without notice, Speakers are invited, pending confirmation
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Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA recommends the reservation at the following hotel
Leipzig Marriott Hotel
Am Hallischen Tor 1
04109 Leipzig,
Germany
PDA Europe has reserved a limited number of rooms until the 31st March 2023.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
The Hotel is located in the center of Leipzig, around 20 minutes car ride from Leipzig/Halle Airport.
The hotel does not offer a shuttle bus.
There are several options for transportation from Leipzig/Halle Airport to the hotel.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
€2.045GovernmentMember Only
€970
Health AuthorityMember Only
€970
Early Career ProfessionalMember Only
€970
AcademicMember Only
€970
Non-Member
€2.345
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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