122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries

122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries

On this episode, I was joined by Jim Fries, CEO of Rx360.

On this episode, 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. 00:04 Guest Introduction: Jim Fries 05:45 The Concept and Process for 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 Licensable Audit Reports 20:34 Challenges in the Industry and the Benefits of Joint Auditing 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 Rx360

Jim Fries has touched the healthcare industry for 25 years. For the last 5 plus years he has led Rx-360, a nonprofit industry pharmaceutical consortium, dedicated to supply chain integrity, material quality, and patient safety.
Jim’s background before Rx-360 was geared towards building and leading organizations in the medical device, and diagnostic arena. He has led advisory and guideline committees in the cardiovascular and diabetes arena, authored multiple CPT codes, has also been a delegate to the WHO, and has also led many FDA pathway groups. Jim joins us today as a lifelong advocate of patient safety.

www.rx-360.org
jfries@rx-360.org

Denne episoden er hentet fra en åpen RSS-feed og er ikke publisert av Podme. Den kan derfor inneholde annonser.

Episoder(248)

241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework.Rather than reviewing the guideline sect...

10 Jun 10min

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances a...

3 Jun 11min

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.The core question behind ICH Q12 is simple: once a ...

27 Mai 10min

239 - ICH Q11 in 6 Minutes

239 - ICH Q11 in 6 Minutes

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.He places Q11 in context with...

20 Mai 6min

238 - 6 Audit Strategies Every Auditor Should Know

238 - 6 Audit Strategies Every Auditor Should Know

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode,...

13 Mai 10min

237 - ICH Q10: The Pharmaceutical Quality System

237 - ICH Q10: The Pharmaceutical Quality System

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style...

6 Mai 8min

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how i...

29 Apr 12min

235 - ICH Q8: How Pharmaceutical Development Actually Works

235 - ICH Q8: How Pharmaceutical Development Actually Works

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.ICH Q8 defines...

22 Apr 10min

Populært innen Vitenskap

fastlegen
tingenes-tilstand
forskningno
vett-og-vitenskap-med-gaute-einevoll
liberal-halvtime
rekommandert
sinnsyn
rss-paradigmepodden
jss
fjellsportpodden
villmarksliv
dekodet-2
hva-er-greia-med
rss-inn-til-kjernen-med-sunniva-rose
tomprat-med-gunnar-tjomlid
rss-rekommandert
kvinnehelsepodden
diagnose
grunnstoffene
rss-zahid-ali-hjelper-deg