FDA announced July 8, 2010 that it will soon begin to conduct 21 CFR Part 11 inspections. Are you ready? In this Webinar, John Avellanet will detail how to prepare yourself for coming Part 11 audits by FDA, as well as how to comply with the revised EMA Annex 11.

What You Will Learn:

  • Status of Part 11 and Annex 11
  • New requirements
  • Major differences between the new interpretations and the old versions
  • Risk-based validation justification details
  • Leveraging vendor efforts, documentation and services
  • The challenges in managing electronic records
  • Recent FDA warning letters related to computer systems and e-records
  • What inspectors will look for around IT compliance and electronic records
  • Recommendations for compliance implementation

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“It was a pleasure listening to your webinar on 21 CFR Part 11 this week. I spoke with management and they are interested in your assistance with our SAP validation.”

“John Avellanet’s frequent speaking engagement requests from the industry are a reflection of his expertise and reputation. In 2009, we got to see this first hand. John helped us on a business-critical project expected to last 9 months. Midway through, senior management challenged us to expedite the project by 3 months and we succeeded thanks to John’s dedication to get the job done – and done right. If I had to characterize John and his firm Cerulean in 3 phrases, they’d be: expert, on-time and high integrity.”

Attendees will receive these free gifts:

  • 3-month subscription to FDA Digest – 483/warning letter e-newsletter
  • Complimentary recording of the event
  • 3-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
  • Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
  • “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)

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