Get 3 days of hands-on Part 11/Annex 11 compliance
and inspection prep training from the same instructors
who trained the FDA and Health Canada
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
This course also includes a complete update on FDA’s latest Part 11 “tag-along” inspection initiatives.