Navigating FDA Inspections: From SOP to 483
Learn how to prepare for an FDA inspection, write an inspection SOP, manage the visit and close-out, know 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 regulatory and quality teams in the spotlight, and the outcome depends on planning, training and composure. This 60-minute FDA inspection readiness webinar gives medical device and pharmaceutical professionals the reasoning, strategies and flows to plan for and manage an inspection from SOP to 483.
You'll review the types of inspections, how to prepare, which people and facility resources to dedicate, and whether to run internal audits, mock audits or both. The session explains what an FDA inspection SOP should contain and how to behave during the inspection, including what to say, what not to say and how to say it.
It also covers the close-out interview, best practices for responding to the 483, and the limits of FDA's scope, such as documents you don't have to show and rules on photographs and affidavits.
Why attend: Compliance usually works in the background, but during an inspection it is front and center, and a poor showing can put the company at risk. Knowing what to expect before, during and after the visit makes the difference. This session suits quality auditors, compliance officers, executives and training staff, and managers and personnel in regulatory affairs, QMS, QA, QC, product development, engineering, manufacturing, risk management and complaint handling.
What’s covered
- Types of inspections
- Preparing for an inspection
- 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: what to say, what not to say and how to say it
- The inspection process and close-out interview
- Limits of FDA's scope: documents you need not show, photographs and affidavits
- Best practices for responding to the 483
- Common questions: advance notice, where the inspector may go, tours, what they see, who they talk to 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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