# 155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-09-25
- Length: 25m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/155---FDA-Compliance-Programs--Program-7536-000-CDER-vs--CDRH-led-Inspections--Mock-PAIs--Supplier-Management--and-What-is-a-Manufacturer--with-Laurie-Auerbach-e2or6j6

## Summary

Laurie Auerbach, President of Compliance Prodigies, LLC, explains FDA Compliance Program 7356.000, clarifying that contract manufacturers (CMOs) and component suppliers selling bundled solutions are legally defined as combination product manufacturers. She highlights common failures in mock Pre-Approval Inspections (PAIs), particularly the misconception that drug GMPs (21 CFR 211) and ICH Q10 fully satisfy device requirements under 21 CFR Part 4. Auerbach emphasizes that sponsors often fail to audit suppliers for device-specific elements like design control, risk management, and specific supplier controls, leading to critical gaps in quality agreements and inspection readiness.

## Chapters

- [0:56](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p#t=56) Introduction to FDA Compliance Program 7356.000
- [4:38](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p#t=278) Inspection Guides and Cross-Referencing QMSR
- [4:58](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p#t=298) Definition of Combination Product Manufacturer and CMOs
- [9:20](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p#t=560) Challenges in Mock Pre-Approval Inspections (PAIs)
- [16:32](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p#t=992) Supplier Management and Quality Agreements
- [24:19](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p#t=1459) Contract Manufacturers and Design Control Responsibilities

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Compliance Prodigies, LLC (company)
- FDA (other)
- Compliance Program 7356.000 (other)
- 21 CFR Part 4 (other)
- 21 CFR 211 (other)
- 21 CFR 820 (other)
- ICH Q10 (other)
- QMSR (other)

## Related episodes from other shows

- [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)
- [#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)
- [FDA is Expanding its Case for Quality Program... Should Your Company Participate?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate) (Global Medical Device Podcast)
- [Most Common Problems Found During FDA Inspections in 2022](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022) (Global Medical Device Podcast)
- [Preparing for Remote and On-Site Inspections and Audits](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits) (Global Medical Device Podcast)

## Citing this page

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