Similarities and Differences Between an FDA and MHRA Audit
Overview:
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
Why should you attend: The reason to attend would be to gain insight in dealing with these two regulatory bodies. To gain an understanding of their requirements and how to best prepare for their audits.
Areas Covered in the Session:
- Regulatory requirements
- Specific differences
- Audit approach
- Audit response
- Audit behavior
- Points to consider
- How to prepare
- Got-ya issues
Who Will Benefit:
- Compliance personnel
- QA personnel
- validation personnel