Topics
- Internal and External Auditing for Part 11 Compliance
- How to prepare and host FDA inspection when Part 11 is in scope
- Overview and Correlation of Part 11 with other regulations
- Audit Trails: Ins and Outs
- Sample Audit Questions
- Trends, Warning Letters, Advantages and Disadvantages of Compliance/Use of Part 11
Who should Attend
Regulatory Affairs, IT/ IS, Quality Engineers, Product development engineers, Internal and External Quality Auditors, Quality Managers, CAPA investigators, Management Representatives and Project managers.