The 21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits is a webinar that covers topics such as:
- What the regulations mean, not just what they say
- Which data and systems are subject to the regulations?
- Examine the regulatory requirements for 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
- Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures
- Electronic signatures, digital pens, and biometric signatures
- Product features to look for when purchasing COTS software
- SOPs required for the IT infrastructure
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
The 21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits brings together attendees from QA, IT, Laboratory staff, QC, GMP, GCP, GLP professionals and Managers.
