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:
- Data integrity, especially in product manufacturing and clinical trials
- Supplier quality assurance
- 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.