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2023 Good Aseptic Manufacturing_1988x680

2023 PDA Good Aseptic Manufacturing Conference

May 23 - May 24, 2023
Leipzig, Germany

Solutions for Implementation of New EU GMP Annex 1 in Current Operations

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  • Europe
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Program Highlights

The Agenda is out now!

Overview

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
  • Richard Denk, SKAN
  • Rainer Glöckler, ten23 heath
  • Gabriele Gori, Thermo Fisher
  • 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, Junior Manager Programs & Events, PDA Europe
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Agenda

Download full Agenda
  • Day 1
  • Day 2

  • 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

    In this session you will learn about the authorities’ expectations for implementation of the new Annex 1 e.g., regarding the application of QRM. Also, the impact for aseptic fill & finish, manufacturer and user will be presented and discussed.

    09:15 I Keynote: Title to be announced
    Regulatory Speaker invited

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

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

    10:45 I Title to be announced
    Regulatory Speaker invited

    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 - 13:40 | Lunch Break, Poster Session & Exhibition

    13:40 - 15:00 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.

    13:40 I Gloveless Robotic Filling Line - How to Meet Regulatory and Industry Requirements
    Aleks Kapun, Novartis
    Julian Petersen, Groninger

    14:05 I Challenges for New Technologies in Sterile Medicinal Products - Outlined in the Revised Annex 1 Regulation 
    Alan Kelly, PM Group

    14:30 I Q&A, Discussion

    13:40 - 15:00 I Session 1 Track B: Contamination Control Strategy
    Moderator: Tracy Moore, TM Pharma Group

    13:40 I Contamination Control Strategy - From the Requirements of Annex 1 to Implementation
    Helen Sauter, Vetter

    14:05 I Sterility Assurance and Contamination Control Strategies
    Aaron Mertens, Steris

    14:30 I Q&A, Discussion

    15:00 - 15:30 | Coffee Break, Poster Session & Exhibition

    15:30 - 17:05 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.

    15:30 I PDA ANSI Standard Approach to Quality Risk Management in Aseptic Processing
    Amanda McFarland, ValSource

    15:45 I Packaging Materials for Sterilization Process According to New Annex 1
    Sara Iacoponi, AM Instruments

    16:10 I Implementation of PUPSIT to Compliment Annex 1
    Terri Love & Stuart Rolfe, Merck KGaA

    16:35 I Q&A, Discussion

    15:30 - 17:05 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.

    15:30 I Development of a Holistic Aseptic Training Program – A Lifecycle Approach
    Patrick Nieuwenhuizen, Pharmalex

    15:45 I Fast Release of Sterile Primary Packaging Containers Using a Rapid Microbial Method: Case Study
    Greta Franzoso, Stevanato
    Lucia Ceresa, Charles River

    16:10 I Moving Forward on Direction to Continuous and Real-Time Environmental Monitoring for Aseptic Filling
    Petra Merker, Bayer

    16:35 I Q&A, Discussion

    17:05 | End of Conference Day 1 and Networking Event

  • Wednesday, 24 May 2023

    09:00 - 10:20 I Session 3: Operators, Training & Qualification
    Moderator: Gabriele Gori, Thermo Fisher

    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 & Speaker invited, J&J

    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
    Gary Feehan, Abbvie
    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

    Speakers will focus on the various aspects and share their experience on how innovative developments could be the perfect answer and/or how to integrate Annex1 prescriptions and the consequences on concepts up to real implementation of a filling area for high potent drug substances and curious to collect inspector’s thoughts and feed-back related to material transfer from Grade C/D environment to Grade A restricted Barriers.
    This closing session will also give the time to collect and summarize the lesson learned of these two days event and give a taste of what will be seen during the Visit to IDT Biologika.

    13:10 I Interactive Questionnaire Session

    13:20 I Manual Aseptic Processing for Advanced Therapies - From Manual to Fully Automated Fill & Finish
    Thorsten Heafner, 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 Title to be announced
    Regulatory Speaker invited

    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

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

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Travel

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.

Leipzig Marriott Hotel

Am Hallischen Tor 1
Leipzig, Germany

Make a Reservation
 
  • Accommodations

    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.

  • Amenities

    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.

Other Options

Leipzig's main train station is located within 350 meters walking distance.

Directions

Registration Fees

Early Registration
Registration Type Price by 26 March
Member €1.845
Non-member €2.145
Govern./Health Authority/Academic €870
Early Career Professional (Member) €870

Prices are only valid for the two-day conference. Additional fees apply for the IDT Biologika site visit. Please book your seat here.













Regular Registration
Registration Type After 26 March
Member €2.045
Non-member €2.345
Govern./Health Authority/Academic €970
Early Career Professional (Member) €970

Prices are only valid for the two-day conference. Additional fees apply for the IDT Biologika site visit. Please book your seat here.




Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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