# 123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-02-14
- Length: 45m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/123---Uncovering-HUGE-Quality-Issues--Inspection-Readiness-in-2024--Data-Integrity--AlCOAPICS-and-Critical-Thinking-in-Quality-Management-with-Peter-Baker-e2fnv57

## Summary

Peter Baker, President of Live Oak Quality Assurance and former FDA Drug Investigator, discusses his career uncovering data integrity breaches in overseas manufacturing facilities. He explains that 99% of data integrity issues stem from poor process design and 'right environment' failures rather than human error, urging companies to shift from compliance-focused checklists to quality-driven critical thinking. Baker highlights specific field failures, such as the manipulation of product quality by blending failed batches with passing ones, and emphasizes the importance of honest reporting of unknown discrepancies to ensure patient safety.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=0) Introduction: Peter Baker and Live Oak Quality Assurance
- [3:01](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=181) Early FDA Career: Imports, Food, and Program Alignment
- [6:01](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=361) Overseas Inspections in India and China
- [10:36](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=636) Root Causes of Data Integrity: Process Design vs. Human Error
- [18:28](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=1108) Unconventional Inspection Methods and Red Flags
- [25:03](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=1503) Manipulation of Product Quality and Blending
- [29:34](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=1774) Why QC Labs are the Primary Target for Falsification
- [35:16](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=2116) Inspection Readiness 2024: Quality vs. Compliance
- [37:04](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a#t=2224) Addressing Unknown Discrepancies and Deviations

## Topics

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

## Most relevant to

established companies

## Mentioned

- Live Oak Quality Assurance (company)
- FDA (company)
- Catherine Ebon (other)
- Bottle of Lies (other)
- Redica Systems (company)
- PIC/S (other)
- MHRA (company)
- Do Quality Differently (other)
- The Wager (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)
- [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)
- [#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech) (Global Medical Device Podcast)
- [Quality Myths and Lessons Learned](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned) (Global Medical Device Podcast)
- [Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020) (Global Medical Device Podcast)

## Citing this page

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