This webinar provides linkage between CAPA and the complaint file. It focuses on risk assessment and impact assessment as tools for linkage between complaint handling and the CAPA life cycle.
Why should you attend?
Complaint file management is the most sited element by FDA Inspectors. The problems are compounded by the confusion in the industry about leakage between the CAPA system and the complaint system. This webinar establishes the linkage between CAPA, risk assessment, impact assessment to the complaint file.
Areas Covered in the Session:
1. Regulatory requirements for complaint handling
2. Regulatory requirements for CAPA
3. Impact assessment
4. Risk assessment
5. Complaint handling process map.
Who will benefit: (Titles)
· Quality managers
· Quality Engineers
· Process Engineers
· Manufacturing Engineers.
Mr. David N Muchemu has over fifteen years experience in Medical Device, Pharmaceutical, Biomedical and Tissue industries as CAPA Training Instructor, Process validation Instructor, Change control Instructor, and CGMP consultant. He has held major positions at Abbott labs, Genentech, Boston Scientific, and Johnson and Johnson. He holds degrees in Biology, Chemical Engineering, and is currently working an MBA with a concentration in Public Health. He is an established author of several GMP books.
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