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

Det här avsnittet är hämtat från ett öppet RSS-flöde och publiceras inte av Podme. Det kan innehålla reklam.

Avsnitt(267)

259 - The Career Lesson I Learned the Hard Way in Pharma

259 - The Career Lesson I Learned the Hard Way in Pharma

Career growth in pharma and medical devices takes technical knowledge, leadership, and the ability to earn your team’s trust. In this episode, Subhi Saadeh shares a lesson from leading a drug-device c...

19 Okt 5min

258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and...

12 Okt 34min

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 ...

5 Okt 12min

256 - The New FDA Inspection Playbook: Where to Start with QMSR

256 - The New FDA Inspection Playbook: Where to Start with QMSR

QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382...

28 Sep 9min

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this ...

21 Sep 11min

254 - Saying No Is the Easy Part of Quality

254 - Saying No Is the Easy Part of Quality

Quality has a reputation for saying no.Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer.In this episode, Subhi breaks down four situations where Quality should abs...

13 Sep 12min

253 - FDA Is Making Big Changes to Its Inspection Approach

253 - FDA Is Making Big Changes to Its Inspection Approach

FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ insp...

7 Sep 45min

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually m...

31 Aug 13min

Populärt inom Vetenskap

dumma-manniskor
p3-dystopia
allt-du-velat-veta
angestpodden
kapitalet-en-podd-om-ekonomi
rss-ronden
rss-ai-med-jonas-benjamin
halsorevolutionen
rss-mottagningen
rss-ufobortom-rimligt-tvivel
sexet
rss-kriminologerna
bildningspodden
det-morka-psyket
medicinvetarna
rss-vetenskapsradion-2
rss-experimentet
rss-vetenskapsradion
rss-spraket
ufo-sverige