CSV – EU GMP Annex 11

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

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


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