Topics
- Types of audit trails and Strategies of implementing compliant audit trails
- Subsection of Part 11 and Interpretation of the subsection
- Audit Trail As an Auditing Tool
- Audit Trail Pros and Cons
- What if’s?
- Audit Trail Shoulds and Shouldn’ts
- What is next about 21 CFR Part 11
- Commonly asked questions about Audit Trail
Who should Attend
Quality Auditors, Quality Managers, CAPA Investigators, Small Business Owners, Software Engineers and Developers, FDA Inspectors and Consultants.
21 CFR part 11 deals with the Food and Drug Administration (FDA) guidelines on electronic signatures and electronic records in the United States.
