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 seminar provides an overview of the Part 11 Regulation and FDA expectations regarding compliance...