# 168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-12-25
- Length: 13m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-25-168-audits-audits-audits-why-they-matter-in-pharma-medical-devices-and-personal
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/168---Audits--Audits--Audits-Why-They-Matter-in-Pharma--Medical-Devices--and-Personal-Growth-e2snlk6

## Summary

Subhi Saadeh, host of Let's Combinate and Quality Professional, discusses the parallel between Peter Drucker’s book 'Managing Oneself' and the role of audits in pharma and medical device industries. He explains the three levels of audits—first-party (internal), second-party (supplier), and third-party (regulatory/certification)—and their specific purposes in ensuring compliance with regulations like ISO 13485 and 21 CFR Part 4. Saadeh emphasizes that audits are systematic, evidence-based appraisal activities designed to reveal system weaknesses and build trust with regulators and patients, rather than just catching mistakes.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-25-168-audits-audits-audits-why-they-matter-in-pharma-medical-devices-and-personal#t=0) Introduction: Peter Drucker's 'Managing Oneself' and Self-Assessment

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

early-stage companies

## Mentioned

- Let's Combinate (other)
- Managing Oneself (other)
- Peter Drucker (other)
- ISO 13485 (other)
- FDA (other)
- 21 CFR Part 4 (other)
- ISO 19011 (other)

## Related episodes from other shows

- [Auditing the Auditor](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor) (Global Medical Device Podcast)
- [For the Love of Internal Auditing](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing) (Global Medical Device Podcast)
- [What are the Audit Etiquette Rules I Should be Following?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-12-what-are-the-audit-etiquette-rules-i-should-be-following) (Global Medical Device Podcast)
- [Ajay Panwar | Statistical Control Processes, Regression Analysis, and Philanthropy](https://hardwarepodcasts.com/podcast/being-an-engineer/2022-03-18-ajay-panwar-statistical-control-processes-regression-analysis-and-philanthropy) (Being an Engineer)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-25-168-audits-audits-audits-why-they-matter-in-pharma-medical-devices-and-personal. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.