GMP Detox 21 CFR Part 11 Time Travel
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- Опубликовано: 7 сен 2024
- Predicate Rules, Federal Register - US-FDA
US-FDA 21 CFR Part 11 - 1997 - final rule
US-FDA Guidance for Industry - Part 11 - Validation, Time Stamp etc. (Draft Versions)
ISPE - Risk-based approach Part 11 - Letter (2003)
Guidance for Industry - Part 11 - Scope and Application (Draft - Feb. 2003 / Final August 2003) - narrow interpretation
Type of signature - applicable sections of 21 CFR Part 11
Comply with ERES - Procedural and Technical considerations - Responsibilities by contract giver AND contract acceptor
Share Responsibilities - Matrix
How to Comply with Part 11....
This channel is gold for anyone in pharma ‼️
Really nice content and good for refreshing memory and getting some of the background.
Glad you enjoy it!