Hardware Podcasts

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

Let's Combinate · 14 Feb 2024 · 45m

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
Live Oak Quality Assurance, FDA, Redica Systems, MHRA
Also
Catherine Ebon, Bottle of Lies, PIC/S, Do Quality Differently, The Wager

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