Description

Course Description

FDA inspections are nerve-wracking events in the lives of regulatory compliance professionals. They are in charge of compliance, usually in the background, and an FDA inspection puts them in the spotlight.

It is therefore critical to have a good understanding of the key elements of regulatory non-compliance, what to expect during the inspection, and critical steps to take post-inspection. Adequate planning and understanding can create an environment for a successful inspection.

This session will discuss how to prepare for the FDA inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Learning Objectives:

By attending this webinar you’ll learn how to:

• Take a proactive approach to FDA inspections
• Identify key elements of regulatory noncompliance and post-inspection activities
• Communicate to the FDA about how your quality systems assure a consistent and compliant state of control
• Respond to a 483 or warning letter correctly the first time

Areas Covered

• Types of FDA inspections
• Preparation
• Dedicated personnel for inspection
• Facility resources to support the inspection
• Internal audits
• SOP for inspections
• Behavior during inspection: What to say and do, and what not to say and do
• Inspection process
• How and when to craft a written response?

Who will Benefit

GMP-regulated manufacturing facilities including pharmaceuticals, medical devices, biologics, food and nutrition, and any other organization that has employees executing activities in which they can make mistakes. Titles that will benefit include:

• Quality Auditors
• Compliance Officers
• Executive Management
• Regulatory Compliance and Regulatory Affairs
• Quality Management System
• Quality Assurance
• Product Development
• Engineering
• Manufacturing
• Complaint Handling
• Personnel new to the regulated industry
• Training personnel
• Document Control Personnel

About the Instructor

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.

Prior to working full-time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem-solving, and quality system methodologies.

José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, where he led the successful tooling, process development, and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

View other FDA webinars:

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

Data Integrity Compliance for Computer Systems Regulated by FDA