Are you looking to stay up-to-date with the regulations?
Whether it's refreshing your own memory, or re-training your internal teams, this training session is a great resource for any Life Science professional
The American regulation 21 CFR Part 11: Electronic Records; Electronic Signatures has been one of the most significantly difficult regulations for healthcare manufacturers to understand and implement since its conception and authorisation in 1997.
Educate your personnel to the requirements of 21 CFR 11 & Annex 11, Electronic Records: Electronic Signatures. This presentation reviews the text and common interpretation of the regulations, including technological and procedural controls required for systems to be compliant with the regulation.
The presentation contains:
- Overview and explanation of 21 CFR Part 11 and Annex 11 principles
- Differences between US and EU regulations
- Expectation from regulatory authorities
- Examples of practical implementation scenarios for 21 CFR Part 11 and Annex 11
- 21 CFR Part 11 and Annex 11 in your organization
- Question & Answer
