Similarities and Differences Between an FDA and MHRA Audit
This webinar will explain FDA and MHRA Audit and compare some of the similarities and differences, and how to best prepare for their audits.
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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:
Who Will Benefit:
- Regulatory Requirements
- Specific Differences
- Audit Approach
- Audit Response
- Audit Behavior
- Points to Consider
- How to Prepare
- Got-ya Issues
- Compliance Personnel
- QA Personnel
- Validation Personnel
Louis Angelucci is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries.
Lou has worked for several well know companies inclusive of Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. This work experience was acquired either as a direct employee or as a contracting consultant while employed at Foster Wheeler and Aker Kvaerner. As a consultant Lou has worked at various project locations both domestically and overseas.
Lou is a member of the IVT board of Directors and has been a contributing speaker to IVT since the organization's early beginnings. He has published numerous articles on the subjects of Validation and compliance and has been a speaker to industry groups such as ISPE, IDE, PDA and ASQ.
Lou is currently employed by Validant a Quality, Regulatory and Engineering consulting firm with expertise in biotechnology, pharmaceutical and medical device industries. Lou is a Quality Systems Consultant specializing in Validation and Quality System Consent Decree administration and remediation.