{"podcast":{"title":"Let's Combinate - Drugs + Devices","slug":"let-s-combinate-drugs-devices-4474248","podcast_index_feed_id":4474248,"rss_url":"https://anchor.fm/s/6770b9a0/podcast/rss","website_url":"https://letscombinate.com","image_url":"https://d3t3ozftmdmh3i.cloudfront.net/staging/podcast_uploaded_nologo/17254408/17254408-1735275370987-64c671ec88d89.jpg","author":"Subhi Saadeh","episode_count":261,"summary":"Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!","last_synced_at":"2026-09-07T22:17:41.545168+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248"},"episode":{"title":"253 - FDA Is Making Big Changes to Its Inspection Approach","slug":"253-fda-is-making-big-changes-to-its-inspection-approach","published_at":"2026-09-07T10:00:00+00:00","page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/253-fda-is-making-big-changes-to-its-inspection-approach","show_page_url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248","url":"https://podcasters.spotify.com/pod/show/letscombinate/episodes/253---FDA-Is-Making-Big-Changes-to-Its-Inspection-Approach-e3oe86q","audio_url":"https://anchor.fm/s/6770b9a0/podcast/play/125296282/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-8-6%2F431309904-44100-2-11977dca946cf.mp3","summary":"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. Timestamps 00:00 Introduction 00:48 FDA’s generalist and specialist inspection models 03:52 What is Bioresearch Monitoring (BIMO)? 05:03 What makes someone an effective FDA investigator? 08:39 Technical expertise versus auditing and inspection skills 11:25 What FDA investigators are actually looking for 14:07 Eric’s experience conducting 800–1,000 inspections 15:11 How investigators prepare, inspect, and write reports 19:44 Why FDA investigators sometimes “phone home” 23:35 The transition from ORA to OII 28:00 What responsibilities remain within OII? 30:31 FDA inspections versus investigations 33:05 The IOM, QSIT, and investigator discretion 38:25 How industry should use FDA compliance programs 44:13 What companies waste time preparing for 45:55 Where to find Eric About Eric Pittman Eric 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, devic…","meta_description":"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…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2753,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-combinate-drugs-devices-4474248/episodes/253-fda-is-making-big-changes-to-its-inspection-approach/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/253-fda-is-making-big-changes-to-its-inspection-approach.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}