21 CFR Part 11 - Compliance for Electronic Records and Signatures 2018

Topics

• 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

Who should Attend

• QA
• IT
• Laboratory Staff
• QC
• GMP, GCP, GLP Professionals
• Managers