21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel 2010

  • 02 Nov 2010
  • Webinar

Description

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

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Important

Please, check "21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance

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