CSV – EU GMP Annex 11

This is how your training course could look like:

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Please note that we need about 3 months preparation for the organisation of your in-house training course.

08.30 - 09.00	Introduction / Expectation of the Participants / Aim of the Event / Annex 11 Overview
09.00 - 09.30	Annex 11 Inventory How to create a CSV compliant inventory
09.30 - 10.15	CSV Roles & Responsibilities, Risk Management
10.15 - 10.30	Morning coffee break
10.30 - 11.00	Electronic Signature Requirements Which areas must have an e-Sig? Batch release
11.00 - 12.30	Data Integrity Requirements How to get systems in the state of control to survive in-spections?
12.30 - 13.15	Lunch

13.15 - 14.00	Audit Trail and Audit Trail Review Pragmatic approach to ATR. Which capacity is needed?
14.00 - 14.30	Supplier Audits Risk based approach
14.30 - 14.45	Coffee break
14.45 - 15.30	IT Infrastructure Qualification Main elements to qualify
15.30 - 16.00	IT Security Requirements User administration, access control
16.00 - 16.30	CSV Findings during Health Authority Inspections
16.30 - 17.00	Q & A