Data Integrity Workshop to comment PIC/S PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments” draft 3

Data Integrity Workshop to comment PIC/S PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments” draft 3

Berlin, Germany

Course No 17196


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Each round table will have two rapporteurs who will be responsible for collecting the review comments during each round table discussion. At the end of a session, all comments from all round tables will be collected by two rapporteurs who will merge and collate all the review comments into a single report.

Frank Behnisch, CSL Behring GmbH, Germany

Frank is Senior Manager Project Engineering at CSL Behring GmbH in Marburg, Germany

Dr Markus Dathe, F. Hoffmann-La Roche AG, Switzerland

GMP Coordinator in the Small Molecules Technical Development of Roche since 2011.

Dalia Elwakil, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Svend Martin Fransen, Biogen Manufacturing ApS, Denmark

Svend is Business Analysis Manager for PO&T IT at Biogen in Denmark. Currently involved in Biogen Data Integrity projects.

Eberhard Kwiatkowski, PharmAdvantageIT, Germany

Member of the GAMP D-A-CH Forum

Dr. Bob McDowall, R.D.McDowall Limited, Bromley, UK

He is a core member of the GAMP Data Integrity SIG and member of the ECA DI IT interest group.

Karl-Heinz Menges, Regional Authority Germany

Head of the German Inspectors Working Group and the German delegate of the PIC/S Expert Circle for computerised systems.

Margarita Sabater, Dako Denmark A/S, an Agilent Technologies Company

Member of the ECA QC Group.

Yves Samson, Kereon AG, Basel, Switzerland

Yves is founder of Kereon AG, Basel. He is member of GAMP Europe Steering Committees and member of the ECA DI IT interest group.

Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche Ltd., Switzerland

Wolfgang is chairman of the ECA DI IT interest group and member of the ECA Advisory Board.

Dr. Robert Stephenson, Rob Stephenson Consultancy, UK

Long-standing member of the GAMP Europe Steering Committee.


Pharmaceutical inspectors from more than 50 countries have joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) now. One of the main objectives of PIC/S is developing harmonised GMP/GDP guidelines. The PIC/S provides guidelines – PI-xxx- for its inspectors which are aimed to support them in the course of inspections. These documents are publicly available and contain questions that could be asked during authority inspections.

The PIC/S is currently working on the revision of elaboration of draft guidance PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments”. The second draft of the document was originally published on 10 August 2016 and released for discussion. The extensive internal comments have been consolidated by the PIC/S and resulted in a revised third draft. This third draft was published on 30 November 2018. ECA has been invited to comment this new draft.

Target Group

This workshop is designed for managers and staff from health care industries as well for auditors who are responsible for Data Integrity in their companies. Participants are invited to give their comments to draft 3 of the PIC/S document PI 041-1.


All attendees should read PIC/S 041 before joining the workshop.
The document can be downloaded from the PIC/S webpage


The PIC/S document PI 041-1 draft 3 from a regulator’s point of view
Karl-Heinz Menges

  • Why does PIC/S create a document on Data integrity?
  • Relevance of the document for inspectors and industry
  • Structure of the document

The PIC/S document PI 041-1 draft 3 from an industry’s point of view
Bob McDowall
  • Comparison of PI-041 and other data integrity guidance from regulatory authorities
  • Harmonisation and inconsistencies of approach
  • Is anything missing from the PIC/S guidance?

In different round table sessions attendees will have the opportunity to comment the PIC/S PI 041-1.
All attendees will comment on the complete document.

Round Table session 1:
  • Chapter 5: Data governance system
  • Chapter 6: Organisational influences on successful data integrity management
  • Chapter 7: General data integrity principles and enablers
Round Table session 2:
  • Chapter 8: Specific data integrity considerations for paper-based systems
Round Table session 3:
  • Chapter 9 Part 1: Specific data integrity considerations for computerised systems (subchapter 9.1 to 9.3)
Round Table session 4:
  • Chapter 9 Part 2: Specific data integrity considerations for computerised systems (subchapter 9.4 to 9.8)
Round Table session 5:
  • Chapter 10: Data integrity considerations for outsourced activities
  • Chapter 11: Regulatory actions in response to data integrity findings
  • Chapter 12: Remediation of data integrity issues
  • Additional comments to Role of suppliers

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