Data Integrity in New Technologies & launch GAMP 5 2nd edition

Learn from experts talking about their experiences with Data Integrity in New Technologies in Manufacturing and Clinical. Think about what and how Pharma 4.0 could help to mitigate Data Integrity pitfalls.

Share your best practices and discuss with peers about industry hot topics and concerns related to Data Integrity. Send us your topic and/or questions upfront (via website, during registration process).

During this event the **NEW** GAMP 5 Second Edition will be presented! The GAMP 5 guide has been updated with Critical Thinking, Agile software development, efficient testing practices, artificial intelligence, and much more! GAMP 5 2nd ed. can be ordered with a 10% discount during this event (by ISPE members only, and cannot be combined with any other offer).

GAMP2ndEdition

This event includes presentations, interactive discussion groups and networking opportunities (dinner and drinks).

The 3 discussion groups are on:

  • DI & Manufacuring (GMP)
  • DI & Clinical (GCP)
  • DI & Pharma 4.0.

The event is open for both ISPE members (free of charge) and non-ISPE members. Registration is required, limited seats.

Directions

Public transport (preferred): The Life Science Campus at Pivot Park can be reached easily by train. From ‘s-Hertogenbosch and from Nijmegen a train leaves to Oss central station 4 times per hour. From the central station to Pivot Park is a short walk of about 10 mins (1 km); follow the signs to Pivot Park.

By car: Limited, paid parking places available! From ‘s-Hertogenbosch follow highway A59 to Nijmegen and take exit 52-Oss. At the traffic lights turn right to “Centrum”. Follow directions for industry parks Oss, next “Moleneind” and “Pivot Park”. From Arnhem/Nijmegen follow highway A50 and A59 to ‘s-Hertogenbosch and take exit 53 to N329 direction Oss. Follow directions to industry park “Moleneind” and “Pivot Park”. The parking lot address is “Kloosterstraat 9, 5349 AB  Oss”. 

Event Properties

Event Date 11-Oct-2022 13.30
Capacity 80
Registered 73
Individual Price EUR40.00
Location Pivot Park, Oss (NL)

Agendas

13:30

Registration & networking

14:00

Welcome at ISPE GAMP COP Benelux

By Chairman of GAMP COP Benelux

14:10

Welcome by Vivenics and Pivot Park

By Petrik Cuijpers - Vivenics

14:20

Computer Software Assurance and launch of GAMP 5 2nd.ed.

By Frans Boeijen - iValidate.it
In GAMP®5 2nd edition, launched during this event, Critical Thinking takes an important role. Critical Thinking is part of FDA CSA, or Computer Software Assurance. According to FDA CDRH it should replace Computer System Validation (CSV). But what is wrong with CSV? And is CSA really new? What do we know about CSA? And when do we get more information on CSA from FDA? Many questions, and (hopefully) some answers in this presentation.

14:40

Working in the cloud with Data Integrity

By Geert Wiers - QSW
The current industry is working more and more with systems which are (partly) cloud based. On the other side, Data Integrity has been a major concern over the last 15 years. Question is, is cloud based working instead of localized working impacting Data Integrity issues? As a start we need to understand what Data Integrity means to those present. With that shared understanding we will evaluate the impact of cloud based working on Data Integrity. Finally an answer is sought on the question “what are the remaining challenges regarding Data Integrity”?

15:10

Digitalisation in GCP

By Chris Nieuwkoop - QbD Clinical
In the clinical environment, digitalization is a slow process requiring the input of many different stakeholders. In this presentation we will be taking a look at the basic set-up of a clinical trial and the systems which are used to accommodate the data integrity needs of all stakeholders. A summary of the data integrity benefits and pitfalls will be highlighted for the most popular systems available in clinical trials.

15:40

Coffee break

Coffee, tea and refreshments are supplied by our sponsor.

16:10

Data Integrity as part of Pharma 4.0

By Hans Heesackers
Groundbreaking evolutions in molecular biology and digital technologies propel the life science industry into an era of product diversity and life cycle management. It requires us to move away from the mass production principles embedded in our thinking to new possibilities accompanied with new GxP controls. This presentation aims to target all your bright engineering brains to what “can be” if we use other business lines and industries to extrapolate our future.

16:40

Short break

Making arrangements for the Round Table dicussions

16:45

Round table discussions round 1

Topics: Data Integrity
in the cloud, Pharma 4.0, GCP

17:25

Round table discussions round 2

Topics: Data Integrity
in the cloud, Pharma 4.0, GCP

18:10

Q&A, Wrap-up and Closing

18:30

Dinner + networking

Time for networking during the dinner, sponsored by Vivenics.
Please let us know when you do not want dinner, so we do not have to waste food! Thanks!

20:00

End

Speakers

Petrik Cuijpers

Managing Director Vivenics

Petrik has 25 years of experience in the pharma industry. In 2012 he was one of the founders of Vivenics, a company providing lab informatics services with a special emphasis on data created and used in the labs. Vivenics consultants have a lot of expertise in data management with a focus on data integrity, data security, data privacy and most recently also data science and AI. Petrik has always worked in roles bridging IT and R&D business, typically in roles like IT project or IT program manager. One of his most recent assignments was project manager for a data integrity remediation project.

Frans Boeijen

iValidate.it

Frans started his career in life science industry in 1985 and has worked in Pharma since then. He has experience with IT, validation and quality management in pharma. As a self-employed trainer since 2005 he delivers training on validation of IT-systems within GxP. He is a founding member of GAMP COP Benelux and very interested in all aspects of DI and quality assurance in computerised systems.

Geert Wiers

QSW

Geert has been working for 37 years in the life-science industry ranging from government to multinational and from the Medical Nutrition to Bio-pharmaceutical production. The first eleven years Geert spent in production thereafter he always worked in Quality Assurance. Within QA he covered all aspects, from systems to investigations, training and validation. As of 2005 Geert operated as a self-employed consult for his own company QSW. Geert prefers to work on the border of operations, production or technical department, and QA. In that area his primary attention goes to the people. His motto is that systems, technical as well as QA, should make the life of the people working with those systems, easier. Ultimately his goal is to build QA and now DI into the normal day to day way of working.

Hans Heesackers

Hans started his career in the life science industry in 1988 and has exclusively worked in this industry ever since. Throughout his career, he worked in different responsibilities in the GMP, GCP, GDP and Supply Chain Management areas, giving him a holistic view on improvement potential from both a quality and a business performance perspective. From 2017 to 2020, Hans was co-chair of ISPE’s global community on Pharma 4.0 where, together with Christian Wölbeling and Thomas Zimmer. He gave strategic direction to the initiative and co-authored multiple articles.

Chris Nieuwkoop

QBD

Chris started his career in the life science industry in 2018 as a CSV Engineer for QbD where he was involved in a number of CSV projects for multiple clients. He has experience with IT and validation of ERP & MBR systems within pharma production environments. A year ago, he switched his focus to the clinical project environment, being involved in a range of clinical studies as well as the eTMF validation project within QbD Clinical. He will be sharing his views on GCP & data integrity within the clinical setting.

Sponsors