21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s

Why Should You Attend:

This webinar describes exactly what is required to be 21 CFR Part 11 compliant. It takes the concepts of Part 11 and expands them into specific things to do in all three primary areas: SOPs, product features, and validation. All required IT SOPs are described. Product features based on the current industry standards are explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.

This is the first webinar in a series and it takes the mystery out of what is needed for 21 CFR Part 11 compliance. It will help you to eliminate 483s and Warning Letters.

Areas Covered in the Seminar:

  • Which data and systems are subject to Part 11.
  • What Part 11 means to you, not just what it says in the regulation.
  • Avoid 483 and Warning Letters.
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
  • Ensure data integrity, security, and protect intellectual property.
  • Understand the current computer system industry standards for security, data transfer, and audit trails.
  • Electronic signatures, digital pens, and biometric signatures.
  • SOPs required for the IT infrastructure.
  • Product features to look for when purchasing COTS software.
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents.

Who Will Benefit:

  • Computer System users
  • IT
  • QA
  • Managers
  • Executives