Navigating Audits in Med Tech and Pharma: A Conversation with Jim, CEO of RX-360
In this episode of the Combinate podcast, host Suby interacts with Jim, CEO of a member-driven consortium, RX-360, that focuses on supply chain integrity, material quality, and patient safety. Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, its working, and benefits. He addresses the challenges faced, emphasizing the need for relationship building and constant growth via listening and questioning. Lastly, he invites audience feedback to continually improve the show.
00:00 Introduction and Welcome
00:04 Guest Introduction: Jim, CEO of a Med Tech Consortium
00:58 Appreciation for Listener Feedback
01:27 Invitation for More Feedback and Contact Information
01:49 Introduction to the Combinate Podcast
02:51 Discussion on Audits with Jim
03:38 Jim's Journey and Role in RX 360
03:56 The Impact of RX 360's Work
05:45 The Concept of Joint Audits
06:59 The Process of Joint Audits
10:03 Regulatory Compliance and Audit Scoping
15:07 Reevaluation and Frequency of Audits
16:33 Evaluating RX 360's Ability to Conduct Audits
19:13 Understanding the Role of RX 360 in Auditing
19:41 The Concept of Licensable Audit Reports
20:34 Challenges in the Industry and the Benefits of Joint Auditing
22:37 The Importance of Supplier Involvement in Audit Sharing
23:31 Addressing the Challenges in Auditing
23:49 The Role of Education in Joint Auditing
25:39 The Impact of RX 360's Working Groups
27:37 The Origin and Evolution of RX 360
29:59 The Importance of Networking and Relationship Building
35:28 How to Connect with RX 360