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EduQuest's most popular classroom course for more than 20 years.

  • Understand and comply with FDA and EU rules for data integrity and security
  • Learn from the very best: experts who wrote the rules, teach FDA inspectors, train industry Quality and IT specialists, and who themselves were expert FDA investigators
  • Learn how to ensure your records and reports withstand the toughest scrutiny by FDA and third-party inspectors
  • Be taught real-world ways to audit the proper validation of COTS, custom, hybrid, and vendor-hosted (cloud-based) computerized systems

Learn from former FDA investigators and policy-makers, including the author of the original Part 11 rules, as well as expert advisors who train and consult for global industry.

Receive expert advice from ex-FDA senior officials, former inspectors, and industry authorities.

Keep your company safe from FDA’s stepped-up enforcement in three areas directly impacted by Part 11 and computer systems validation:

  1. Data integrity, especially in product manufacturing and clinical trials
  2. Supplier quality assurance
  3. Audit trails and change control in virtual computing environments, including “Software as Service” and cloud computing

 This course also includes a complete update on FDA’s latest Part 11 “tag-along” inspection initiatives and a thorough explanation of the EU's Annex 11 rules and their relationship with Part 11.