Hardware Podcasts

253 - FDA Is Making Big Changes to Its Inspection Approach

Let's Combinate · 7 Sept 2026 · 45m

What this episode covers

Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific generalist model under the new Office of Investigations and Inspections (OII). He details the operational differences between routine inspections under Section 704 and undercover investigations under Section 702, emphasizing that investigators prioritize human subject safety over minor regulatory technicalities. Pittman advises industry to focus on the FDA’s Investigations Operations Manual (IOM) and specific compliance programs rather than cosmetic facility improvements, noting that the end of QSIT has shifted focus to broader process evaluation.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, Project Farma, Temple University
Also
Bioresearch Monitoring, Investigations Operations Manual, QSIT

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