# 242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-06-17
- Length: 12m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-17-242-pharma-medtech-audits-6-strategies-for-choosing-where-to-start
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/242---PharmaMedTech-Audits-6-Strategies-for-Choosing-Where-to-Start-e3ksv8t

## Summary

Subhi Saadeh, founder of Let’s Combinate, outlines six audit strategies from the ASQ Certified Quality Auditor (CQA) Body of Knowledge for pharma, biotech, and combination product audits. He details the Tracing, Process Approach, Process-Based Management, Department, Element, and Discovery methods, explaining how each strategy applies to auditing suppliers, manufacturing sites, or quality systems. Saadeh emphasizes selecting the correct tactic based on whether the goal is verifying evidence, identifying bottlenecks, or surfacing hidden risks.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-17-242-pharma-medtech-audits-6-strategies-for-choosing-where-to-start#t=0) Introduction: Subhi Saadeh and Six Audit Strategies

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- CQA Academy (other)
- ASQ (other)
- ISO 9001 (other)
- ISO 13485 (other)

## Related episodes from other shows

- [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)
- [Auditing the Auditor](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor) (Global Medical Device Podcast)
- [How to Select a Contract Manufacturer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer) (Global Medical Device Podcast)
- [R&D RADIO: How to Audit a Co-Packer: The Food QA's Hermi Galstian Explains](https://hardwarepodcasts.com/podcast/the-startup-cpg-podcast/2026-08-17-r-d-radio-how-to-audit-a-co-packer-the-food-qas-hermi-galstian-explains) (The Startup CPG Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (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/2026-06-17-242-pharma-medtech-audits-6-strategies-for-choosing-where-to-start. 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.