253 - FDA Is Making Big Changes to Its Inspection Approach

FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ inspections, led the Bioresearch Monitoring Division West, and served for a decade as editor-in-chief of FDA’s Investigations Operations Manual.In this episode, Eric explains how FDA investigators are trained to think, the difference between technical expertise and inspection skill, why investigators sometimes “phone home,” and what the transition from ORA to OII means for the agency’s inspection model.We also discuss BIMO inspections, the difference between inspections and investigations, the end of QSIT, and how companies can use FDA’s Investigations Operations Manual and compliance programs to prepare more effectively.Timestamps00:00 Introduction00:48 FDA’s generalist and specialist inspection models03:52 What is Bioresearch Monitoring (BIMO)?05:03 What makes someone an effective FDA investigator?08:39 Technical expertise versus auditing and inspection skills11:25 What FDA investigators are actually looking for14:07 Eric’s experience conducting 800–1,000 inspections15:11 How investigators prepare, inspect, and write reports19:44 Why FDA investigators sometimes “phone home”23:35 The transition from ORA to OII28:00 What responsibilities remain within OII?30:31 FDA inspections versus investigations33:05 The IOM, QSIT, and investigator discretion38:25 How industry should use FDA compliance programs44:13 What companies waste time preparing for45:55 Where to find EricAbout Eric PittmanEric Pittman is Vice President of Quality Assurance and Regulatory Affairs at Project Farma. Before moving into industry, he spent more than 20 years at FDA across drugs, devices, foods, biologics, and bioresearch monitoring.He served as Division Director for Bioresearch Monitoring West, was the U.S. delegate to the OECD Working Party on Good Laboratory Practice, and spent a decade as editor-in-chief of FDA’s Investigations Operations Manual. Eric is also an adjunct professor in Temple University’s QA/RA graduate program.Connect with EricLinkedIn: https://www.linkedin.com/in/ericspittmanmba-fdaProject Farma: https://projectfarma.comAbout Subhi SaadehSubhi Saadeh is a combination-product quality professional, consultant, and host of Let’s Combinate: Drugs + Devices. His work focuses on the intersection of pharmaceutical and medical-device requirements, including combination-product quality systems, design controls, supplier quality, manufacturing, inspection readiness, and regulatory strategy.Through Let’s Combinate, Subhi brings together regulators, industry leaders, and technical experts to make complex drug-device topics easier to understand and apply.Connect with SubhiLinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/YouTube: https://www.youtube.com/@LetsCombinateWebsite: https://letscombinate.com