PDA Good Aseptic Manufacturing Conference 2025
Excellence in Aseptic Manufacturing: Bridging Compliance, Innovation, and Sustainability
Networking Opportunities, Exhibit Area
Become a Sponsor and/or Exhibitor
Call for Posters
Closing on 04 April 2025
Registration Options
Individual Registration
Group Registration
Discover the Excellence in Aseptic Manufacturing at the PDA Good Aseptic Manufacturing Conference 2025
Bridging Compliance, Innovation, and Sustainability
On behalf of the PDA and the Scientific Program Planning Committee, we are delighted to welcome you to the PDA Good Aseptic Manufacturing Conference 2025, taking place in Basel, Switzerland, from 22 - 23 May 2025. As part of PDA Good Manufacturing Week 2025, this premier event will bring together industry leaders, regulatory experts, and innovators to explore the latest advancements in aseptic manufacturing..
Aseptic manufacturing is at a critical juncture, with emerging technologies, evolving regulatory expectations, and sustainability imperatives shaping the future of the industry. The threats of contamination, stringent sterility requirements, and the need for operational efficiency make it critical to stay ahead of challenges and innovations. This conference is designed to provide practical insights that go beyond theory, equipping attendees with the knowledge and tools to ensure product integrity, regulatory compliance, and patient safety.
A rich lineup of presentations awaits, complemented by ample opportunities for networking during coffee and lunch breaks. And don’t miss our evening networking event, a chance to connect in a more informal setting, and be sure to explore the scientific posters showcasing innovative research and projects from leading experts.
We look forward to the valuable connections, knowledge sharing, and innovations this conference will inspire – all set against the vibrant and inspiring background of Basel.
Optional Pre-Conference Site Visits
PDA Site Visit at ten23 health 2025
Learn about different technologies in development and manufacturing of sterile drug products.
Learn more about the site visitPDA Site Visit at SKAN 2025
Choose between a digital focused part or an aseptic focused part to deepen your knowledge.
Learn more about the site visitWhat to Expect
The conference features a diverse and in-depth agenda covering key topics relevant to the pharmaceutical industry, delivered by a distinguished lineup of expert speakers:
- Regulatory and Compliance Updates: Gain insights from regulatory agencies , and an intergovernmental organization on the evolving landscape of EU GMP Annex 1 and its implications for aseptic manufacturing
- Innovation in Aseptic Processing: Explore next-generation technologies and how to engage healthcare professionals with new solutions
- Parallel Tracks: Participate in focused sessions covering key topics such as first air principles, decontamination, enablers for aseptic manufacturing, closed systems, aseptic process simulation, particle risk mitigation, and the application of quality risk management.
- Interactive Learning and Engagement: Engage with experts in panel discussions and roundtables, explore cutting-edge research and real-world applications in poster sessions and guided walks, and gain practical takeaways from industry leaders through speed talks and case studies highlighting innovative aseptic solutions
Why Attend the Conference?
Join this preeminent gathering of industry and regulatory experts, and technology innovators. The PDA Good Aseptic Manufacturing Conference 2025 offers:
- Strategic Insights: Gain firsthand knowledge of how aseptic manufacturing is evolving and the steps needed to stay compliant and innovative
- Practical Takeaways:Discover real-world applications of new technologies and strategies to enhance sterility assurance, efficiency, and sustainability
- Networking Opportunities: Meet global industry experts, regulators, and peers, and engage in meaningful discussions on the future of aseptic manufacturing
Join us in Basel, and be part of the movement driving excellence in aseptic manufacturing.
Sincerely,
The Co-Chairs
Simone Biel, Merck
David Keen, Ecolab
The conference will take place right after the PDA Good Digital Manufacturing Conference 2025 as part of the PDA Good Manufacturing Week 2025! Make the best of your journey and attend two conferences in one week!
Register for the Syntegon Pharmatag and gain insights into the future of fill-finish technologies. Attend thought-provoking keynotes, explore real-world case studies, and join an exclusive plant tour. The day will conclude with an evening event to connect and exchange ideas. This year’s theme, 'Tomorrow’s Pharma Technologies Today,' sets the stage for discussions on innovation and progress.
Secure Your Spot TodayProgram Highlights
The agenda preview is out now! Explore the sessions and secure your spot today!
Agenda
Discover What's Happening Each Day
CEST Daylight Time (UTC +2:00)
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Welcome and Introduction
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Committee:
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Welcome from the Co-Chairs
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Co-Chair:
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Co-Chair:
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Opening Plenary Part I
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Moderator:
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From Good Manufacturing to Good Use of Treatments
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Presenter:
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The new Annex 1: source of challenges and driver of innovation – an agency perspective
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Regulatory Presenter:
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Advancing Aseptic Fill & Finish: A Collaborative Breakthrough in Next-Generation Production
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Networking Coffee Break, Exhibition
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Opening Plenary Part II
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Moderator:
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A Holistic Approach to Addressing Value Chain Emissions
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Interactive Questionnaire Session
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Plenary Discussion
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Guided Poster Walk
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Networking Lunch Break, Poster Session, Exhibition
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Session 1 Track A Closed Systems
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Moderator:
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A Risk-based Approach for Assuring the Integrity of Closed, Single-use Systems in Aseptic Processing
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Integrity Assurance of Final Sterile Filtration Process Step with SuS
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Case Study of Aseptic Processing in a Closed System in Clean Room Class C
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Q&A, Discussion
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Session 1 Track B Enablers for Aseptic Manufacturing
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Moderator:
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Replace Settle Plates with Continuous Active Air Monitoring inside a production isolator
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Revision of Technical Report No. 33 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods
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The Digital Transformation of Sterility Testing- The Case for Alternative Microbiological Methods with Complex Product Formulations
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Q&A, Discussion
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Networking Coffee Break & Exhibition
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Session 2 Track A First Air
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Title to be announced
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Latest Technologies to Follow First-Air Principles According to Annex 1
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Session 2 Track B Decontamination
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Moderator:
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Application and Qualification of an Automated UV Disinfection Robot for Aseptic Cleanrooms
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Case Study: E-Beam Used More Than 15 Years as Transfer Technology for RTU Pre-Filled Syringes at Pfizer Grange Castle Ireland on Multiple Filling Lines
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Q&A, Discussion
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End of Conference Day 1 & Networking Event
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Session 3 Track A Aseptic Process Simulation
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Moderator:
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EU GMP Annex 1, QRM & APS: Practical Approach & Points to Consider
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Aseptic Process Simulation: Pragmatic Approach for Key Topics
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Q&A, Discussion
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Session 3 Track B Particle Risk Mitigation
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Moderator:
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Total Particle Count: two options to be compliant to Annex1: 3-way valve redesign, Counter resistant to VHP
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Achieving Particle Reduction via Supplier Annex 1 Strategies and Innovation in RTU / RTF Packaging
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Networking Coffee Break, Poster Session & Exhibition
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Session 4 Track A Excellence in Manufacturing Execution
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Moderator:
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Session 4 Track B Application of Quality Risk Management
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Applying QRM and QbD Principles to Fill-Finish Equipment: A Scientific Approach to Measure Risk Reduction
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Title to be announced
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Q&A, Discussion
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Networking Lunch Break, Poster Session & Exhibition
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Award Ceremony
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Closing Plenary Part I
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Moderator:
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Interactive Questionnaire Session
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Regulatory Expectations on Data-Driven Sterile Manufacturing
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Nudge Theory: What Is It and How People Can Be Influenced to Make Better Decisions in Aseptic Manufacturing
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Plenary Discussion
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Networking Coffee Break, Poster Session & Exhibition
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Raffle Card Announcement
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Best Poster Presentation
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Closing Plenary Part II
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Interactive Round Table Session
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Co-Chairs Conference Summary
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Closing Remarks & Farewell
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Program Planning Committee
The Team Behind the Event's Agenda
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Caroline Lynar
Parenteral Drug Association
Manager Programs & Events
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Christina Meissner, PhD
AGES - Austrian Agency for Health and Food Safety GmbH
Group Manager
Read Bio -
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Promotions and Press
Request Press Pass
Submit Your InformationLocation and Travel
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
Movenpick Hotel Basel
Aeschengraben 25
Basel, 4051
Switzerland
PDA Europe has reserved a limited number of rooms until 14 April 2025.
Book your room at the PDA Group Rate using the above-mentioned reservation button.
Travel in Style with Lufthansa Group Airlines
We are excited to partner with Lufthansa Group Airlines to offer discounted flights for attendees of the PDA Good Aseptic Manufacturing Conference 2025!
Special Offer Details:
Use the exclusive discount code: MCDE6230
Take advantage of reduced fares to make your travel to the conference both convenient and cost-effective. Don’t miss this opportunity to join us while enjoying a seamless travel experience!
How to Get Here
Area Attractions
- Kunstmuseum Basel (10-minute walk)
- Basel Minster (15-minute walk)
- Old Town (15-minute tram ride)
Did you know? Basel is known as the “city of fountains” with over 170 beautifully crafted fountains scattered throughout the city. Many of them date back centuries!
Registration
Pricing Options
Standard Registration
Member Price
€2,390GovernmentMember Only
€1,200
Health AuthorityMember Only
€1,200
Early Career ProfessionalMember Only
€1,200
StudentMember Only
€1,200
AcademicMember Only
€1,200
Non-Member
€2,690
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.
Presenters
Meet the Experts
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Darren Beckett
Fedegari Technologies, Inc.
Sr. Training and Technology Center Manager
Committee Member
Moderator
Read Bio -
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Raquel Casañ Crespo, MSc
Novo Nordisk A/S
Project Manager
Co-Presenter
Panelist
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Tarik Cheema, PhD
F. Hoffmann-La Roche AG
Process Unit Lead DP (GEF)
Committee Member
Moderator
Panelist
Presenter
Read Bio -
Ginette Collazo
Presenter
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Richard Denk
SKAN AG
Senior Consulting Aseptic Processing & Containment
Committee Member
Moderator
Read Bio -
Paul Devuyst, Master Bioengineer
GSK
Senior Manager Aseptic Technologies
Committee Member
Panelist
Presenter
Read Bio -
Hauke Fender, PhD
BioNTech Innovation and Services Marburg GmbH
QA Expert Aseptic
Panelist
Presenter
Read Bio -
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Alina Gruber
Panelist
Presenter
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Vincent Hamers
AstraZeneca
Site Microbiologist / Development Quality Biologics Microbiologist
Co-Presenter
Panelist
Read Bio -
Markus Heinz, MSC
Syntegon Technology GmbH
Strategy and Global Product Management
Co-Presenter
Panelist
Read Bio -
Isabelle Hoenen, PharmD
Lilly France SAS
Senior Advisor Quality for Sterility Assurance
Co-Presenter
Panelist
Read Bio -
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Jonathan W. Kallay
Charles River Laboratories
Scientific Portfolio Specialist
Panelist
Presenter
Read Bio -
David Keen, MRSB CBiol
Ecolab Life Sciences
Director Pharmaceutical Microbiology & Consulting
Co-Chair
Moderator
Presenter
Read Bio -
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Falk Klar, PhD
Parenteral Drug Association
General Manager, Vice President Europe
Committee Member
Presenter
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Morcos Mikhail Fahmy Loka, MBA, CMQ/OE, CQA, CPGP, CPIP
Minapharm
Quality Senior Manager Biologics F&F and New Projects
Panelist
Presenter
Read Bio -
Caroline Lynar
Parenteral Drug Association
Manager Programs & Events
Committee Member
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Christina Meissner, PhD
AGES - Austrian Agency for Health and Food Safety GmbH
Group Manager
Committee Member
Moderator
Regulatory Presenter
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Nicola Rutigliani
Panelist
Presenter
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Andrea Salmaso, PharmD
Stevanato Group
Corporate Regulatory and Scientific Affairs Manager
Committee Member
Moderator
Read Bio -
Helen Sauter, Dr
Vetter Pharma Fertigung GmbH & Co. KG
Director Quality Assurance
Committee Member
Moderator
Read Bio -
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Brian Thome, PhD
Biogen
Head, External Biologics and Gene Therapy Manufacturing Sciences
Panelist
Presenter
Read Bio -
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Paula Walser, Doctorate in Chemistry
Swissmedic
Head of GMDP Inspection Operations
Panelist
Regulatory Presenter
Read Bio -
Jerome Weiss
Co-Presenter
Panelist
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Patrick Wieland, MA
Bausch+Ströbel SE + Co. KG
Global Director Business Development
Panelist
Presenter
Read Bio
Sponsors
Sponsors and Collaborators
Sponsorship and Exhibit Opportunities are available!
For more information about exhibit and sponsorship opportunities, please contact:
Christopher Härtig
Senior Manager Exhibition & Sponsorship
Email
Exhibitors
Exhibitors and Innovators
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- Bausch+Ströbel SE + Co. KG
- Charles River
- Chemie Brunschwig AG
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- GASPOROX AB
- Honeywell Life Science
- Innerspace
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- MBV AG
- Mesa France SA
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- pixon engineering AG
- QualiMetrix S.A.
- Rotzinger PharmaPack GmbH
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- Steriline S.r.l.
- STERIS
- Syntegon
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- Test
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