Understanding and interpreting the requirements of the 21 CFR Part 11 Regulation can be a difficult and daunting task. Many device manufacturers are caught unawares during FDA Inspections when questioned about compliance to Part 11. This workshop provides your staff with a basic understanding of the requirements of Part 11, the concept of shared responsibility, and provides concrete examples of how to meet the requirements in the most cost-effective and efficient manner.

This workshop can be tailored to the specifics of your current Quality System. As a result, you can immediately identify areas of potential regulatory exposure. By applying the techniques presented in this workshop, you can minimize or eliminate any potential exposure and improve the effectiveness of your process validation activities.