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.
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