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A Comprehensive Guide to Audits and Compliance in Pharmaceuticals

A Comprehensive Guide to Audits and Compliance in Pharmaceuticals

FromQueens of Quality Podcast


A Comprehensive Guide to Audits and Compliance in Pharmaceuticals

FromQueens of Quality Podcast

ratings:
Length:
38 minutes
Released:
Aug 15, 2023
Format:
Podcast episode

Description

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 Hosts0:02:14 - Qualification and Requalification Process Discussion0:08:32 - Misconceptions About Vendor Qualification0:19:04 - Document Access and Audit Scheduling Issues0:24:16 - The Importance of Quality in Business0:30:07 - Harmonizing Global and Local Operations0:33:29 - Assessing Data Entry Accuracy and Guidelines0:36:08 - Hosts' final thoughts and sign-off Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect!Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com
Released:
Aug 15, 2023
Format:
Podcast episode

Titles in the series (19)

Quality and compliance are often seen as rigid within an organization. Every company has ‘em; nobody wants ‘em, but it’s even more imperative to implement them. Join, Michelleanne and Jen, host of Queens of Quality, the podcast, as they discuss topics in reasonable and, at times, light-hearted delivery. Receive insight on how these requirements can be implemented in a compliant, scale-able, and sustainable manner for organizations at any point within the company life cycle. Every week, we will provide solutions for day-to-day issues to debunk some of the misconceptions about Quality Assurance. Subscribe to the show to stay up to date with new episodes.