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

Combinate Podcast - Combining Drugs and Devices

On this episode, I was joined by Peter Baker, President @ Live Oak QA.

The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical devices and clinical trials, and how operational changes in the mid-2010s streamlined FDA's specialized areas. The speaker discusses his inspection methods and how a focus on critical thinking rather than procedural controls leads to more substantial findings, particularly in data integrity within quality control labs across industries. He emphasizes the need for quality-driven, honest investigations in addressing deviations and believes a switch from a compliance-focused mindset to a quality-oriented one should be the future standard.

00:00 Early Career and Diverse Experiences

00:43 Understanding FDA Regulations and Import Work

02:28 Moving Overseas and Program Realignment

07:44 Challenges with Data Integrity

10:33 Understanding the Root Cause of Data Integrity Issues

10:54 The Role of Data Governance and Regulatory Guidance

22:24 Challenges of Field Inspections

24:07 Manipulation of Product Quality

25:26 Jurisdiction and Quality Systems

27:53 Lab Controls and Data Integrity

36:04 Addressing Unknown Discrepancies

39:34 The Importance of Honest Reporting

Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11.

PIC/S Guidance on Data Integrity: https://picscheme.org/docview/4234

Live Oak: https://www.liveoakqa.com/

Peter's Blog: https://www.liveoakqa.com/blog-1