Discover this podcast and so much more

Podcasts are free to enjoy without a subscription. We also offer ebooks, audiobooks, and so much more for just $11.99/month.

The Evolution of Compliance in Biotech and Pharma with Cheryl McCarthy

The Evolution of Compliance in Biotech and Pharma with Cheryl McCarthy

FromQueens of Quality Podcast


The Evolution of Compliance in Biotech and Pharma with Cheryl McCarthy

FromQueens of Quality Podcast

ratings:
Length:
28 minutes
Released:
Sep 26, 2023
Format:
Podcast episode

Description

In this episode of Queens of Quality, the hosts interview Cheryl McCarthy, a seasoned professional in the pharmaceutical and biotech industries. They discuss the complexities of quality and compliance, the new ICHU6R3 guidance, and the importance of explaining the rationale behind actions. The conversation also explores the evolution of quality control, the integration of Agile methodology, and the shift in quality culture towards collaboration. They conclude by discussing the role of auditors, the potential benefits of constructive feedback, and the learning opportunities presented by audits.Tune in!During this episode, you will learn about;0:00:32: Introduction of the first-ever guest, Cheryl McCarthy, her background, and her consulting group, Anchor.0:03:58: Discussion on the impact of decisions in quality assurance and risk-based approaches.0:08:12: Conversation about the proactive and preventative approach in quality management.0:15:33: Highlighting the importance of collaboration and communication in quality culture.0:18:39: Emphasizing the ultimate target in quality management, which is the patient.0:19:48: Discussion on the need for processes and controls in quality management.0:21:07: Conversation about the value of audits and opportunities for improvement.0:23:54: Acknowledgment of the importance of a collaborative and non-confrontational approach in quality management.0:27:10: Closing remarks and contact information for the podcast.            Love the show? Subscribe, Rate, Review, Like, and Share! Let’s Connect! Connect with Cheryl McCarthy;LinkedIn: https://www.linkedin.com/in/cherylmccarthy/Connect with Queens of Quality;Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com 
Released:
Sep 26, 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.