From Concept to Medicine - A Comprehensive Drug Development Journey

41 - Complaint Handling and Product Recalls Protecting Patients (S19E3)


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Discuss the critical process of managing customer complaints and executing product recalls, emphasizing the importance of effective complaint handling systems. Explore how these systems gather data, investigate root causes, and initiate corrective actions to improve product safety and overall quality. Examine the hallmarks of a really good system and it works to really dig into problems and discover their root cause.

Emphasize the regulatory requirements for prompt recall procedures, risk communication, and comprehensive documentation to protect patient safety while maintaining transparency and continuous improvement in the quality system. Discuss the need to understand requirements from many different regulations and guidelines. Then highlight how to work with them in the field. And how it's all for patient safety and public well being.

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From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

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