Myths vs Facts
- Understanding misinterpretations related to Part 11
- What is really applicable to the industry?
- Breakdown of Myths vs Facts related to Part 11
- What is enforcement discretion and what is means to the industry?
What is out of the scope of enforcement?
- Learn where Part 11 is no longer applicable
- What does out of scope mean to the industry?
Which records are in the scope of enforcement?
- Learn to understand records that must comply with Part 11
- How to identify records that need to comply with Part 11
Assessments tools for Part 11 Compliance?
- Learn how to create tools to assessment Part 11 applicability
- Overview of tools to simplify Part 11 requirements definition
Recent FDA Observations?
- Overview of recent Part 11 FDA observations
- Inspections trends and what they mean to the industry