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Former FDA Inspectors Train Medical Device, Pharmaceutical Companies How to Comply with Latest FDA Expectations for Validation and Part 11
Date:10/29/2010

WASHINGTON, Oct. 29 /PRNewswire/ -- EduQuest has trained hundreds of FDA inspectors; now it trains thousands of those being inspected by the Agency.

A global team of FDA compliance experts, EduQuest is presenting the "FDA Auditing of Computerized Systems and Part 11" training course for quality managers and regulatory specialists December 7-9, 2010, at the Hotel DuPont in Wilmington, Delaware (near I-95, Amtrak rail lines, and the Philadelphia airport). Course topics include:

  • Which validation deliverables the FDA expects and what they should contain
  • Why 50 percent of compliance dollars and resources are wasted on ineffective or inadequate validation
  • Top validation errors cited in FDA enforcement actions
  • Proactive steps to avoid CSV and Part 11 Form 483s and warning letters
  • Part 11 rules for electronic records and signatures
  • Ensuring audit trails and safe, secure data access and transfer
  • Evaluating software vendor compliance claims
  • Current status of Part 11 - revisions, rewrite or abandonment?
  • How to prepare for the FDA inspector - using a simulated inspection with real-world scenarios

    • The course is taught by instructors with experience on both sides of the fence as FDA inspectors and as compliance managers for industry. As a result, attendees receive practical guidance from those who understand the expectations of FDA officials as well as the resource realities faced by regulated industry.

    Over the past 15 years, EduQuest has provided training for FDA's Office of Regulatory Affairs (ORA), the lead office for all of FDA's field activities (including inspections and recalls) and for Health Canada inspectors. The course chairman is Martin Browning, president and co-founder of EduQuest and the former vice chair of FDA's Electronic Record and Signature Work Group, where he helped to write the original Part 11 rules.

    Tuition for the three days of training is $2,795
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    SOURCE EduQuest
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