21 CFR Part 11 - Compliance for Electronic Records and Signatures 2018 is a webinar that covers topics such as:
- What Part 11 means to you, not just what it says in the regulation
- Which data and systems are subject to Part 11
- Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
- Avoid 483 and Warning Letters
- Understand the current computer system industry standards for security, data transfer, and audit trails
- Ensure data integrity, security, and protect intellectual property
- SOPs required for the IT infrastructure
- Electronic signatures, digital pens, and biometric signatures
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
- Product features to look for when purchasing COTS software
21 CFR Part 11 - Compliance for Electronic Records and Signatures 2018 is intended for:
- QA
- IT
- Laboratory Staff
- QC
- GMP, GCP, GLP Professionals
- Managers
