ISPE GAMP Community Of Practice: GAMP - Quality beyond Compliance

Woensdag, 24. April 2019, 13:30 - 20:00

GAMP CoP Benelux invites you to its half-day event about ‘GAMP - Quality beyond Compliance’ at Sanquin, Amsterdam (NL) on 24 April 2019.

Learn more about “quality” as enabler for organizations working in a collaborative environment. Interactive discussion how the Deming Management Method could be implemented in Life Science Industry. Mr. Bill Bellow, Ph.D. (Deputy Director, W. Edwards Deming Institute) gives a keynote speech.

Takeaways about data quality coming from last published industry and regulator guidances (GAMP Data Integrity Good Practice Guide, PIC/S).

Explore and discuss with peers about how to build (and maintain) quality in System Life Cycle documentation management.

Event is open for ISPE members (FREE of CHARGE) and non-ISPE members.

DARQA leden kunnen zich inschrijven op het GAMP COP Portal voor deelname voor een bedrag van voor € 25,-

Er is nu nog plek voor 15 mensen.

Location: Sanquin (Plesmanlaan 125, 1066 CX Amsterdam, The Netherlands)





Welcome & Introduction

GAMP COP Benelux



Mr. Pieter de Geus Ph.D.
- Member of the Executive Board at Sanquin
- CEO Sanquin Plasma Products


Keynote speech about Quality

Deming Management Method
Mr. Bill Bellow, Ph.D. - Deputy Director, W. Edwards Deming Institute
Do you want to know more about Deming Management Method? Join the 8-hours interactive conversation/workshop with Mr. Bill Bellows Ph.D (Deputy Director, W.Edwards Deming Institute) at Amsterdam on April, 25th..


Interactive Q&A session

Interactive Q&A session about takeaways for Life Science Industry
Frans Leijse - GAMP CoP Benelux


Coffee break


GAMP DI good practice guide

Takeaways of last published GAMP DI good practice guide
Tom De Rudder - GAMP Global SIG Data Integrity member


PIC/S guidance about data quality

Takeways of last published PIC/S guidance about data quality
Frans Boeijen –


Coffee break


Documentation management

How to build quality in System Life Cycle documentation management : tools, lessons learned,
Bert Vanlommel, Janssen Pharmaceutica


Q&A session

Discussion about System Life Cycle documentation management tools
Pascal Vande Gucht – GAMP CoP Benelux


Wrap-up & closing

GAMP CoP Benelux


Networking dinner/drinks

sponsored by Sanquin



Contact :
Parking: Visitors are invited to park at the MCS (Medisch Centrum Slotervaart) parking garage located at Louwesweg 12 Amsterdam (which is within 400 metres walking distance of Sanquin reception). After your visit you can collect a free parking ticket at Sanquin reception to exit the parking garage.


MSD, Boxmeer, is looking for a

Senior Specialist QA officer GLP/GCP

responsible for monitoring GLP/GCP compliance of R&D Boxmeer facility

If you are interested in this challenging role, you are requested to apply online at the MSD website.

DARQA Nieuwsbrief

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