# Preparing for Remote and On-Site Inspections and Audits

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-02-24
- Length: 50m
- Episode: 182
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits
- Listen: https://podcast.greenlight.guru/episode/preparing-for-remote-and-on-site-inspections-and-audits

## Summary

Steven Niedelman and Eric Henry from King & Spalding’s FDA and Life Sciences practice discuss strategies for medical device companies to prepare for FDA inspections and audits, particularly in the context of resumed on-site and remote inspections. They emphasize the importance of systemic corrective actions for CAPA issues, preparing for pre-market and for-cause inspections, and conducting thorough mock audits to ensure staff readiness. The guests also advise firms that received QMS exemptions under Section 564A to begin remediation toward compliance with 21 CFR 820 and ISO 13485.

## Chapters

- [2:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits#t=149) FDA Inspection Priorities and MDSAP
- [6:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits#t=387) Preparing for For-Cause and Pre-Market Inspections
- [11:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits#t=689) Addressing CAPA and Systemic Issues
- [13:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits#t=831) QMS Remediation for 564A Exemptions
- [23:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits#t=1407) Inspection Logistics and Front/Back Room Setup
- [33:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits#t=2038) Mock Audits and Staff Training
- [44:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits#t=2640) Remote Inspections and Virtual Tours

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- King & Spalding (company)
- FDA (other)
- Green Light Guru (company)
- MDSAP (other)
- ISO 13485 (other)
- 21 CFR 820 (other)

## Related episodes from other shows

- [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](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness) (Let's Combinate)
- [253 - FDA Is Making Big Changes to Its Inspection Approach](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach) (Let's Combinate)
- [201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-13-201-inside-a-300m-fda-remediation-lessons-from-zimmer-to-epipen-warning-letters) (Let's Combinate)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-24-preparing-for-remote-and-on-site-inspections-and-audits. 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 Global Medical Device Podcast.