The FDA Inspection: Preparation, Performance and Follow-Up
Learn how to prepare for an FDA inspection, manage the inspector and the close-out interview, understand the limits of FDA's scope and respond well to a Form 483.
Speaker
Jeff Kasoff
Quality and regulatory consultant · Lean to Quality, LLC · 30+ years in quality and regulatory
Overview
An FDA inspection puts the people responsible for compliance in the spotlight. This 75-minute FDA inspection training gives medical device and pharmaceutical professionals the rationale, strategies and workflows to plan for an inspection and manage it with confidence.
You'll cover the types of inspections, how to prepare, which company roles to assign, the facility resources you need and whether to run internal audits, mock audits or both. The session explains what an inspection SOP should contain and how to behave during the inspection: what to say, what not to say and how to say it.
You'll also learn the limits of FDA's scope, including documents you don't have to show and the rules on photographs and affidavits, plus how to handle the close-out interview and respond to a Form 483.
Why attend: Does the FDA call first or just show up? Where can the inspector go, what should they see and whom should they talk to? Planning, training and composure make the difference between a smooth inspection and a costly one. The session helps regulated medical device, diagnostic, pharmaceutical and biologics companies, including quality auditors, compliance officers, executives, regulatory, QA, product development, engineering, manufacturing, complaint handling, training and document control staff, and people new to the industry.
What’s covered
- Types of inspections
- Preparing for FDA inspections
- Dedicated personnel for the inspection
- Facility resources to support the inspection
- Internal audits, mock audits or both
- Contents of an SOP for FDA inspections
- Recommended behavior during an inspection: what to say, what not to say and how to say it
- The inspection process and close-out interview
- Limits of FDA's scope, including documents you need not show, photographs and affidavits
- Best practices for responding to a Form 483
- Common questions: advance notice, where the inspector may go, tours, what to show, whom they may interview and how long they stay
Who should attend
What you get
About the speaker
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
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