Part of the Integrity Group of Companies:
Example two day programme
Day One of Training | |
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09:00 – 09:30 | Introduction and determination of what the delegates want/expect from the programme |
09:30 – 10:00 | Laws, regulations and business drivers for CSV |
10:00 – 10:45 | GAMP 5 ® An Industry Approach to CSV |
10:45 – 11:00 | BREAK |
11:00 – 11:45 | Risk management |
11:45 – 12:30 | WS: Risk management |
12:30 – 13:15 | LUNCH |
13:15 – 14:00 | Effective user requirements |
14:00 – 14:45 | WS: Infrastructure Qualification |
14:45 – 15:00 | BREAK |
15:00 – 15:45 | Infrastructure Qualification |
15:45 – 16:30 | Supplier assessment |
16:30 – 17:15 | WS: Supplier assessment |
Day Two of training | |
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08:30 – 09:15 | E-records and signatures |
09:15 – 10:00 | WS: Outline a validation strategy |
10:00 – 10:30 | Validation planning |
10:30 – 10:45 | BREAK |
10:45 – 11:15 | Specifications, design review and traceability |
11:15 – 12:00 | Protocols and testing |
12:00 – 12:45 | WS: Planning testing |
12:45 – 13:30 | LUNCH |
13:30 – 14:15 | Change management |
15:00 – 15:30 | Validation reporting and presentation to inspectors |
14:15 – 15:00 | WS: Change management |
15:30 – 15:45 | BREAK |
15:45 – 16:15 | Data migration |
16:15 – 17:00 | Maintaining control in operation |
17:00 – 17:15 | Wrap Wp WS: Workshop |