Seminar Nr. 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.
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The PIC/S is currently working on the revision of elaboration of draft guidance PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments”.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.
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 www.picscheme.org:
The PIC/S document PI 041-1 draft 3 from a regulator’s point of view