2023 PDA Good Aseptic Manufacturing Conference

Leipzig, Germany
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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.

Note PDA is committed to deliver safe and secure in-person events. In conjunction with the venue and vendors supporting our event, PDA strictly adheres to all national, provincial and local government regulations. PDA is closely monitoring the situation and will continue to update this information if required.

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

Early Bird Pricing

Early Bird Member Price

€1.845

GovernmentMember Only

€870

Health AuthorityMember Only

€870

Early Career ProfessionalMember Only

€870

AcademicMember Only

€870

Non-Member

€2.145

Standard Pricing

Standard Member Price

€2.045

GovernmentMember Only

€970

Health AuthorityMember Only

€970

Early Career ProfessionalMember Only

€970

AcademicMember Only

€970

Non-Member

€2.345

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, 23 May 2023

09:00

Welcome and Introduction
Falk Klar, PDA
Kerstin Wilken, IDT Biologika
Paul Devuyst, GSK

09:15 - 12:40 I Opening Plenary: Regulatory and Industry Updates
Moderator: Kerstin Wilken, IDT Biologika

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.

09:15 I Keynote: Points-to-Consider Implementing EU GMP Annex 1
Tracy Moore, TM Pharma Group
Richard Denk, SKAN

09:45 I Rapid Microbiological Methods in the Light of EU GMP Annex 1
Christina Meissner, Austrian Agency for Health and Food Safety

10:15 - 10:45 | Coffee Break, Poster Session & Exhibition

10:45 I Transfer of People and Materials
Tracy Moore, TM Pharma Group

11:15 I Impact on the Filling Machine, Manufacturer, and User
Rainer Gloeckler, ten23 health
Ralf Wagner, Optima Pharma

11:40 I Interactive Questionnaire Session

11:55 I Q&A,
 Panel Discussion

12:40 - 14:00 | Lunch Break, Guided Poster Session & Exhibition

14:00 - 15:20 I Session 1 Track A: Barrier Systems
Moderator: Richard Denk, SKAN

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.

14:00 I Gloveless Robotic Filling Line - How to Meet Regulatory and Industry Requirements
Aleks Kapun, Novartis
Julian Petersen, Groninger

14:25 I Challenges for New Technologies in Sterile Medicinal Products - Outlined in the Revised Annex 1 Regulation 
Alan Kelly, PM Group

14:50 I Q&A, Discussion

14:00 - 15:20 I Session 1 Track B: Contamination Control Strategy
Moderator: Tracy Moore, TM Pharma Group

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.

14:00 I Contamination Control Strategy - From the Requirements of Annex 1 to Implementation
Helen Sauter, Vetter Pharma

14:25 I Sterility Assurance and Contamination Control Strategies
Aaron Mertens, STERIS Life Sciences

14:50 I Q&A, Discussion

15:20 - 15:50 | Coffee Break, Poster Session & Exhibition

15:50 - 17:25 I Session 2 Track A: Aseptic Processing
Moderator: Peter Makowenskyj, GCon Bio

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.

15:50 I PDA ANSI Standard Approach to Quality Risk Management in Aseptic Processing
Amanda McFarland, ValSource

16:05 I Packaging Materials for Sterilization Process According to New Annex 1
Sara Iacoponi, AM Instruments

16:30 I Implementation of PUPSIT to Compliment Annex 1
Terri Love and Stuart Rolfe, Merck

16:55 I Q&A, Discussion

15:50 - 17:25 I Session 2 Track B: Contamination Control Strategy – Focus Testing
Moderator: Andrea Salmaso, Stevanato Group

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.
The contamination control strategy is the fundamental basis of the new EU GMP Annex 1. This session will introduce some case studies regarding innovative techniques implemented or under implementation for ensuring the quality of components and products.

15:50 I Development of a Holistic Aseptic Training Program – A Lifecycle Approach
Patrick Nieuwenhuizen, PharmaLex

16:05 I Fast Release of Sterile Primary Packaging Containers Using a Rapid Microbial Method: Case Study
Greta Franzoso, Stevanato Group
Lucia Ceresa, Charles River

16:30 I Moving Forward to Continuous and Real-time Environmental Monitoring for Aseptic Filling
Petra Merker, Bayer

16:55 I Q&A, Discussion

17:25 | End of Conference Day 1 and Networking Event

Day 2

Wednesday, 24 May 2023

09:00 - 10:20 I Session 3: Operators, Training & Qualification
Moderator: Darren Beckett, Fedegari

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.
To achieve this, it is critical to define WHAT to train, and HOW to train. The traditional approach, based on providing permanent staff or temporary employees with a mountain of written SOPs to be read and understood does not work.
The next presentations will provide with the “Frame-by-Frame Risk Profiling” a novel approach to identify the areas and activities requiring focus in the training sessions and concrete examples of the use of innovative training approaches based on Augmented Reality & Virtual Reality to effectively address these needs.

09:00 I Human Factor Control Strategy for Aseptic Manufacturing: Introducing a Frame-by-Frame Risk Profiling & Mitigation Approach
Sebastian Scheler, Innerspace & Ron Smith, Johnson & Johnson

09:25 I Facilitating Short and Efficient Training Periods for New Personnel
Henning Künstler, Körber Pharma Consulting

09:50 Q&A, Discussion

10:20 - 10:50 | Coffee Break, Poster Session & Exhibition

10:50 - 12:10 I Session 4: Disinfection/Decontamination
Moderator: David Keen, Ecolab

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.

10:50 I Meeting the Challenges of Annex 1 with Innovation in Rapid H2O2 Validation
Claus Rosenvang, Novo Nordisk
Kate Marshall, Protak Scientific

11:15 I Collaborating to Innovate Effective Disinfectant Rotation Strategies for Contamination Control
Laura Brennan, Ecolab

11:40 I Q&A, Discussion

12:10- 13:10 | Lunch Break, Poster Session & Exhibition

13:10 - 16:35 I Closing Plenary: Application of Aseptic Processing to Various Product Classes
Moderator: Paul Devuyst, GSK

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.

13:10 I Interactive Questionnaire Session

13:20 I Aseptic Processing for Advanced Therapies - From Manual to Fully Automated Fill & Finish
Bianca Bohrer, PSM
Marc Machauer, PSM

13:45 I Implementation of a New Aseptic Filling Area at Sanofi Frankfurt – A Reflection on the Impact of Annex 1 Revision
Rebecca Geyer, Sanofi

14:10 - 14:40 | Coffee Break, Poster Session & Exhibition

14:45 I U.S. FDA Expectations on Barrier Systems
Sandra Boyd, U.S. FDA

15:10 I Biologics Manufacturing and Implementation of Annex 1 at IDT Biologika
Ulrike Fiedler, IDT Biologika

15:35 I Closing Panel Discussion

16:15 I Chairs Conference Summary
Kerstin Wilken, IDT Biologika
Paul Devuyst, GSK

16:30 I Closing Remarks & Farewell
Falk Klar, PDA

16:35 End of Conference

Agenda is subject to change without notice, Speakers are invited, pending confirmation

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
By Air The international airport of Leipzig is "Leipzig/Halle" located 20 km away from the hotel and conference space.
By Car Parking is available on site, € 22.00 per day. The parking fee applies only to guests of the Marriott Hotel in Leipzig.