Computerized Software Validation (CSV)
Engineering & Validation
Starts at: 09:00
Duration: 3 Meetings
Language: Hebrew + English
A full training that includes a comprehensive overview for the validation life cycle for computerized systems in the Pharma and Medical Device industries according to the cGMP, Annex 11, 21 CFR Part 11 requirements and GAMP5 methodology.
The training provides you with the latest regulatory aspects, validation life cycle approach, requirements and real life case studies and in depth sessions on: URS/SRS/FRS/ FDS/ RA/ VP /IQ/ OQ/ PQ/ TRM.
This course will explain how to implement a robust and effective Computer Systems Validation Program using a Risk-Based and Critical Thinking approaches, and how having a good understanding of the organization’s critical data assets will help to implement a sound risk management and data integrity programs as well.
Course date:
18/02/2025
25/02/2025
04/03/2025
TLV
9:00-16:00
Price: 4,500 NIS + VAT
Special discounted early registration price until 20.01.24- 3,825 NIS + VAT
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