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In-house Training Programme

 
 

New EU GMP Annex 11 Regulations for Computerised Systems

 
     
 
When What
  Schedule Day 1
09.00 - 09.30 h Introduction to the Annex 11 Course
09.30 - 11.00 h Identifying the Main Changes to GMP Annex 11 for Computerised Systems
11.00 - 11.30 h Coffee Break
11.30 - 12.15 h Annex 11 Principles and Risk Management
12.15 - 13.00 h Roles and Responsibilities in Computerised System Validation
13.00 - 14.00 h Lunch Break
14.00 - 15.15 h Workshop 1: Assessing the Impact of the New Validation Section of Annex 11
15.15 - 15.30 h Coffee Break
15.30 - 16.00 h EU GMP Annex 11 Electronic Signatures
16.00 - 16.45 h Workshop 2: Electronic Signatures
16.45 - 17.00 h Coffee Break
17.00 - 17.30 h Inventory of Computerised Systems and System Descriptions
17.30 - 18.00 h New Requirements for Vendor Audits
18.00 - 18.30 Final Discussion Day 1
  Schedule Day 2
08.30 - 09.30 h GMP Chapter 4 on Documentation: What are the major changes?
09.30 - 10.45 h Workshop 3: Implementing Chapter 4 and Annex 11 Requirements for Electronic Records
10.45 - 11.15 h Coffee Break
11.15 - 12.00 h Data Integrity Requirements for Computerised Systems
12.00 - 12.30 h Regulatory Issues around the Information Technology Department
12.30 - 13.30 h Lunch Break
13.30 - 14.15 h Security of Networks and Computerised Systems
14.15 - 15.00 h Batch Release
15.00 - 15.15 h Coffee Break
15.15 - 15.45 h Change Control and Configuration Management
15.45 - 16.15 h Periodic Evaluation of Computerised Systems
16.15 - 16.30 h Final Discussion
 
 
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal 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.

 

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