Queens of Quality Podcast

A Comprehensive Guide to Audits and Compliance in Pharmaceuticals

Episode Notes

This podcast episode, hosted by Jen and Michelleanne, dives deep into the intricacies of pharmaceutical and biotech industries, focusing on audits, vendor qualifications, and quality compliance. The hosts unravel how health authorities are intensifying their involvement in vendor collaborations, the increasing importance of contract owners in the qualification process, and the instances where qualification audits become vital for organizations. The episode also delves into vendor qualification and audit scheduling, the role of SOPs and quality manuals, and the challenges of vendor reassessment during mergers and integrations. The conversation concludes with an exploration of respect, empathy, transparency, and open communication in vendor management and how to balance regional requirements in the qualification process. This episode is an enlightening and exciting rollercoaster ride into the world of pharmaceutical vendor management.

 

Tune in!

 

During this episode, you will learn about the following;

0:00:31 - Start of the show and Introduction of Hosts

0:02:14 - Qualification and Requalification Process Discussion

0:08:32 - Misconceptions About Vendor Qualification

0:19:04 - Document Access and Audit Scheduling Issues

0:24:16 - The Importance of Quality in Business

0:30:07 - Harmonizing Global and Local Operations

0:33:29 - Assessing Data Entry Accuracy and Guidelines

0:36:08 - Hosts' final thoughts and sign-off

 

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