21 CFR Part 11 - Compliance for Electronic Records and Signatures

Edwin Waldbusser
Instructor:
Edwin Waldbusser
Duration:
90 Minutes
Product Id:
501306
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
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Overview:

This webinar details the regulation and how it applies to computerized systems.

Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.

Areas Covered in the Session:

  • 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:
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP professionals


Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.




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