Preparing for the Rewrite of 21 CFR Part 11

Validation Week, sponsored by IVT, Philadelphia, PA

I. How to Prepare for the Part 11 Rewrite: Running in Place

• Approaching the rewrite from an operational point of view
• Designing business operations to maximize quality while minimizing costs
• Assessing business and regulatory compliance risks in an appropriate manner
• Best practices for preparation for whatever the FDA will put forth

II. Interactive Exercise

Participants will examine the predicate regulations and FDA expectations to identify where and how the requirements provided in 21 CFR part 11 are already addressed and, in some cases, more effectively addressed. Participants will also identify potential scenarios, and discuss what will make the most sense for the industry.

Bonus Information

• A matrix that traces the requirements of 21 CFR part 11 to applicable predicate regulations
• Documentation outlining FDA’s expectations