New EU GMP Annex 11 Regulations for Computerised Systems

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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

  Content Day 1
09.00 - 09.30 Introduction to the Annex 11 Course
09.30 - 11.00 Identifying the Main Changes to GMP Annex 11 for Computerised Systems
11.00 - 11.30 Coffee Break
11.30 - 12.15 Annex 11 Principles and Risk Management
12.15 - 13.00 Roles and Responsibilities in Computerised System Validation
13.00 - 14.00 Lunch Break
14.00 - 15.15 Workshop 1: Assessing the Impact of the New Validation Section of Annex 11
15.15 - 15.30 Coffee Break
15.30 - 16.00 EU GMP Annex 11 Electronic Signatures
16.00 - 16.45 Workshop 2: Electronic Signatures
16.45 - 17.00 Coffee Break
17.00 - 17.30 Inventory of Computerised Systems and System Descriptions
17.30 - 18.00 New Requirements for Vendor Audits
18.00 - 18.30 Final Discussion Day 1
  Content Day 2
08.30 - 09.30 GMP Chapter 4 on Documentation: What are the major changes?
09.30 - 10.45 Workshop 3: Implementing Chapter 4 and Annex 11 Requirements for Electronic Records
10.45 - 11.15 Coffee Break
11.15 - 12.00 Data Integrity Requirements for Computerised Systems
12.00 - 12.30 Regulatory Issues around the Information Technology Department
12.30 - 13.30 Lunch Break
13.30 - 14.15 Security of Networks and Computerised Systems
14.15 - 15.00 Batch Release
15.00 - 15.15 Coffee Break
15.15 - 15.45 Change Control and Configuration Management
15.45 - 16.15 Periodic Evaluation of Computerised Systems
16.15 - 16.30 Final Discussion

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