2022 ISPE Pharma 4.0™ and Annex 1 Conference

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  • All full-access registration (virtual & in-person) includes access to speaker presentations, on-demand content, and other conference material.
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  • On-demand content is accessible for 90 days.

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Thank You for Making this Conference a Huge Success!


That's a wrap on the 2022 ISPE Pharma 4.0™ and Annex 1 Conference!

On behalf of the event programme committee and the ISPE International Board of Directors, we want to thank our attendees for participating in this event and supporting continuous innovation and improvement within the pharmaceutical industry!


Thank you to our keynote speakers who kicked off the 2022 ISPE Pharma 4.0™ and Annex 1 Conference with compelling and insightful presentations:


Annex 1 Implementation and Challenges

In the revised Annex 1, what was updated regarding container closure integrity testing (CCIT)?

Daniel Boergel, Director Microbiology & Aseptic Technique | Quality Management Generics, Fresenius Kabi Deutschland GmbH highlighted key updates during his session "New Annex 1 Challenges for LVP Bag Manufacturing" at the 2022 ISPE Pharma 4.0™ and Annex 1 Conference.

New Annex 1 Challenges

In the new Annex 1, SVP bags are added to the list of “containers closed by fusion” that will require 100 % container closure integrity testing (CCIT) as final product control. Implementing a 100 % CCIT technology for filled flexible containers presents unique technical challenges and is contrary to the recent year's industry development toward process analytical technology (PAT)

With the Annex 1 implementation period being one year, what are the next steps if the current technology doesn't exist today? Daniel Boergel, Director Microbiology & Aseptic Technique | Quality Management Generics, Fresenius Kabi Deutschland GmbH addressed this question during his session "New Annex 1 Challenges for LVP Bag Manufacturing" at the 2022 ISPE Pharma 4.0™ and Annex 1 Conference.


2022 ISPE Pharma 4.0™ and Annex 1 Conference Gallery

  • Hackathon
    Hackathon
  • Conference Welcome
    Conference Welcome
  • Networking Event
    Networking
  • Conference Session
    Conference Session
  • Conference Session
    Conference Session 2
  • Exhibitors
    Exhibitors
  • Executive Dinner
    Networking Event

Regulatory View on the Holistic Control Strategy and Digital Maturity

Regulation has a powerful impact on innovation: it can stimulate ideas and block their implementation. Given this, how much do regulators understand and support Pharma 4.0 initiatives, and how will they regulate this area in the future?

During the 2022 ISPE Pharma 4.0™ and Annex 1 Conference session "Regulatory View on the Holistic Control Strategy and Digital Maturity," Mark Birse President, Technical, Parexel, explored the role regulators can play in advancing innovation.


Conference Highlights


Program Committee

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Christian Woelbeling
Executive Industry Advisor
Körber
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Jean-Francois Duliere
Pharmaceutical Senior Expert, Vice Chair ISPE France Affiliate
Heike Roeder
Director, Lead Digital Quality, Risk Advisory Life Science
Thomas Zahel, PhD
Head of Innovation
Körber Pharma Austria GmbH
Placeholder Person Graphic
Karine Peron
Head of Technology Management - EMEA
Merck Millipore
Josef Trapl
Head of MSci Innovation, GMS / Manufacturing Science
Takeda Pharmaceutical International AG
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
CRB
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Wolfgang Winter
Director, Informatics Platform R&D
Agilent Technologies R&D Mktg GmbH & Co KG
Bernd Boedecker
Ex-EU GMP Inspector
GMP Freelance Consultant