21 CFR Part 11 and Annex 11 Compliance - specifics needed to eliminate 483s 2015 is a webinar dedicated to
- What Part 11 means
- Data and systems are subject to Part 11
- Three primary areas of Part 11 compliance: software product features, SOPs and validation documentation
- Avoid 483 and Warning Letters
- The computer system industry standards for data transfer, security and audit trails
- Security, data integrity and d protect intellectual property
- SOPs required for the IT infrastructure
- Digital pens, Electronic signatures and biometric signatures
- Product features for COTS software
Who should Attend
IT, Computer System users, Managers, QA and Executives.
