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ISPE GAMP Community Of Practice: GAMP – Quality beyond Compliance

24 April 201913:30 – 20:00

ISPE GAMP Community Of Practice: GAMP – Quality beyond Compliance

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,-

https://www.gamp-benelux.eu/index.php/events/cop-events-2/gamp-quality-beyond-compliance

Er is nu nog plek voor 15 mensen.

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

Agenda

13:30	Registration
14:00	Welcome & Introduction GAMP COP Benelux
14:10	Welcome Mr. Pieter de Geus Ph.D. – Member of the Executive Board at Sanquin – CEO Sanquin Plasma Products
14:20	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..
15:20	Interactive Q&A session Interactive Q&A session about takeaways for Life Science Industry Frans Leijse – GAMP CoP Benelux
16:00	Coffee break
16:30	GAMP DI good practice guide Takeaways of last published GAMP DI good practice guide Tom De Rudder – GAMP Global SIG Data Integrity member
17:00	PIC/S guidance about data quality Takeways of last published PIC/S guidance about data quality Frans Boeijen – iValidate.it
17:30	Coffee break
17:45	Documentation management How to build quality in System Life Cycle documentation management : tools, lessons learned, Bert Vanlommel, Janssen Pharmaceutica
18:30	Q&A session Discussion about System Life Cycle documentation management tools Pascal Vande Gucht – GAMP CoP Benelux
19:00	Wrap-up & closing GAMP CoP Benelux
19:10	Networking dinner/drinks sponsored by Sanquin
20:00	End

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.

Event

ISPE GAMP Community Of Practice: GAMP – Quality beyond Compliance

Agenda

Registration

Welcome & Introduction

Welcome

Keynote speech about Quality

Interactive Q&A session

Coffee break

GAMP DI good practice guide

PIC/S guidance about data quality

Coffee break

Documentation management

Q&A session

Wrap-up & closing

Networking dinner/drinks

End

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