How FDA trains its Investigators to Review CAPA and How should you prepare
🎤 Charles H. Paul | 📅 February 18, 2025 | 🕒 11 AM Eastern Time US
Is Your CAPA System Ready for FDA Inspection?
🔹 What FDA investigators are trained to find? 🔹 Is your CAPA documentation fully compliant? 🔹 Can your processes withstand intense regulatory scrutiny? If you are looking for answers to any of these questions, this webinar is for you. This webinar is essential for professionals across various roles, including Quality Assurance and Control, Regulatory Affairs, Manufacturing and Production, Executive Management and Compliance, as well as CAPA Coordinators and Quality System Auditors. It is designed for anyone involved in pharmaceutical, food, beverage, cosmetics, or medical device manufacturing who interacts with the CAPA system in any capacity. Understanding what FDA inspectors are trained to look for is crucial, and this session provides the insights needed to ensure compliance and avoid regulatory pitfalls. |
The #1 most common finding during an FDA inspection is a flawed CAPA system—and FDA investigators know exactly what to look for when reviewing your CAPA processes. If your CAPA documentation isn’t rock solid, your company could be at risk of compliance violations. The FDA trains its investigators using a structured approach based on official investigative manuals, including:
✅ The FDA’s Operations Manual (IOM) – How investigators assess CAPA documentation.
✅ Compliance Program Guidance Manual 7382.845 – CAPA’s role in FDA inspections.
✅ QSIT Manual – Quality System Inspection Technique – A deep dive into inspectional objectives.
In this highly practical webinar, Charles H. Paul—President of C.H. Paul Consulting and a renowned regulatory expert with 20+ years of experience—will walk you through exactly how FDA investigators are trained to evaluate your CAPA system. You’ll gain insider knowledge on how to audit your own CAPA processes just like an FDA investigator would.
What You’ll Learn:
✔ What FDA Inspectors Are Looking For – Know the exact criteria inspectors use to review CAPA compliance.
✔ CAPA Process Steps Explained – Master the key elements of an effective CAPA system.
✔ Common CAPA Pitfalls – Avoid the biggest mistakes that trigger compliance red flags.
✔ How to Ensure Compliance – Implement CAPA best practices that withstand FDA scrutiny.
✔ Inside the FDA’s Investigative Manuals – Get a breakdown of the key FDA inspection guides.
Key Areas Covered:
- CAPA defined
- CAPA process steps explained
- Challenges and pitfalls of CAPA’s
- Documents Used by FDA Inspectors
- Operations Manual (IOM)
- Problem identification and corrective action
- Requirements
- Recommended Methods of Compliance for Each Requirement
- Compliance Program Guidance Manual 7382.845
- CAPA considerations relative to the inspection process
- QSIT Manual – Quality System Inspection Technique
- Inspectional Objectives
- Decision Flow Chart
- Medical Device Reporting
- Corrections & Removals
- Medical Device Tracking
