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ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track!

Frank Henrichmann
Heather D. Watson
Elena Vulpe, PhD
GAMP® 5 (Second Edition)

GAMP® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the 2023 ISPE Annual Meeting and at several local GAMP® events held around the globe. At the upcoming 2023 ISPE Europe Annual Conference, you will have an excellent opportunity to hear about GAMP® 5 directly from the authors, discuss the content of the guide with peers and regulators, and ask all the questions you did not get answers to until now. As technologies continue to evolve and are being adopted by the pharmaceutical industry at the same time when companies are facing new challenges like pandemics, supply chain issues and drug shortages, it has become even more important that validation approaches smartly address the risks to Patent Safety, Data Integrity, and Product Quality. Computer System Validation should not be a hindrance to innovation. On the contrary, it should enable innovation by ensuring that systems are fit for the intended purpose without creating an excessive documentation burden. It should ensure that investments into novel solutions will improve quality and efficiency in the development, manufacturing, and distribution of treatments that we all might need at some time. This is why validation can never be an exercise in mindlessly filling in templates and completing checklists. Validation is about thinking things through, assessing risks carefully and making justified decisions. This is what GAMP 5 is all about!

The GAMP® track will be hosted by members of the GAMP® Global Steering Committee Frank Henrichmann (Secretary), Heather Watson (Chair) and Elena Vulpe (Emerging Leader) and will include presentations from industry subject matter experts.

On the afternoon of Tuesday, 9th May, Sion Wyn will provide an overview of the changes made to GAMP® 5, the reasoning behind the update, and what it could mean for you and your organization in the session “GAMP® 5 (Second Edition) Overview, Themes, & Objectives”.

The Computer Software Assurance (CSA) concepts published as draft guidance by the FDA and that are already embedded in GAMP® 5 Second Edition will be discussed in detail. Will CSA be accepted outside of the US? What about for something that is not a Medical Device? How do I apply CSA concepts to my projects? What are “the experiences of others when introducing CSA? How is CSA connected to Critical Thinking? During the afternoon of Tuesday, 9th May, get answers to these questions when Guy Wingate is presenting “GAMP® 5 Second Edition Overview Critical Thinking for Smarter Validation” along with the CSA presentation from Khaled Moussally and Ken Shitamoto “Understanding FDA's CSA Guidance in the Context of Current Regulations and GAMP”, who are part of the FDA’s FICSA Team. Finally, try it yourself in exercises during the highly interactive CSA Workshop led by Oliver Herrmann and Elena Vulpe “GAMP 5 Second Edition - Data Integrity / Computer Software Assurance (CSA) Workshop” on the afternoon of Tuesday, 9th May.

2023 ISPE Europe Annual Conference

With ChatGPT being one of the most controversially discussed Artificial Intelligence (AI) solutions ever, Martin Heitmann and Carsten Jasper’s presentation on AI and GAMP® 5 is something you don’t want to miss on the morning of Wednesday, 10th May. After all, AI is seen by most companies as one of the top game-changers for the future. But how do I validate an AI system? Isn’t it just like any other system? Can it be validated at all? What do the regulators expect? Questions like this can be raised during the Panel discussion with our presenters and regulators from the EU at the final session of the GAMP® track on the afternoon of Wednesday, 10th May.

Even though Agile methodologies have been applied to software development and many other areas, there are still organizations that try to squeeze it into a documentation structure that is still based on a waterfall approach and could be summarized like this:

“You need a DS for the IQ, an FRS for the OQ and a URS for the PQ. Link them through a TM, otherwise the FDA will give you a 483!”

Rene van Opstal will provide insights into achieving the same outcome with a paperless validation approach in an Agile environment on the morning of Wednesday, 10th May.

Cyber Security is another heavily discussed topic in the media and is troublesome for many companies and organizations. After all, every security incident may have disastrous consequences for data integrity and/or product quality. How can you still trust your data if an outsider has penetrated your defenses? What are the consequences of stolen, deleted, or encrypted data? What are the appropriate controls and safeguards for systems and organizations? SME Mario Testino will present a self-assessment tool for Cyber Security that will help you to tackle the problem on the morning of Wednesday, 10th May.

In addition to all of this, you will also have the opportunity to hear from Nele Ooms and Bernard Sieben on the subject of “Risk-based digital validation approach for SAP” which will provide insights into how to apply GAMP 5 principles leading to a smart and lean validation in a real-life scenario on the morning of Weds 10th May and John Ward will explore another technology that is included in GAMP® 5 (Second Edition) when he presents on “Blockchain & Smart Pharmaceutical Manufacturing” on the afternoon of Wednesday, 10th May.

As if this isn’t enough to keep you busy with listening to the very informative presentations and asking questions during the “Q&A” session after each presentation, you will also have the opportunity to meet like-minded people with similar challenges during the networking sessions where you will have the chance to discuss ideas, visions, and experiences as beneficial as the information and insights provided by the great speaker line-up.

Learn More & Register!

Looking forward to seeing you at the conference!