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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|