Essential Last Minute Preparation for an Imminent FDA Inspection

Why Should You Attend:

Whether FDA will be arriving in three days, or three weeks, a pre-announced inspection provides one measure of certainty: how much time you have remaining to prepare. Optimizing this remaining time can mean the difference between success and failure, between a clean inspection and having dreaded 483 items to address.

Now is the time to act so that you stay ahead of FDA expectations and prevent a 483 finding that could have been avoided. During this session, you will learn:

• What document updates, memorandums and reports can be created to address potential gaps within the application of your Quality System.
• How to prepare the inspection support team as well as the greater organization for proper behavior and conduct during an FDA inspection.
• How to implement a record collection and presentation strategy, so that you are not surprised by documents provided to the inspector.
• How to conduct background research on the inspector / inspection team, and what their record says about how they will conduct their inspection of your facility.
• How to manage the pace of the inspection so that you, not the inspector, are in the driver’s seat.

Also covered are what last minute activities that should be avoided. Few things can change the tone of an inspection than presenting 'wet ink' records that appear to an auditor to have been created for the inspection.

Areas Covered in the Webinar:

• How to identify high-impact preparation activities.
• How to prioritize these activities to maximize their impact.
• How to prepare the inspection support team.
• How to prepare the entire organization.
• What TO DO at the last minute.
• What NOT to do at the last minute.
• Preparation lessons learned and after action reviews.

Who will Benefit:

The webinar will be beneficial to all device, drug, and biotech manufacturers and is recommended for any individuals or teams that are involved

• Quality Assurance
• Quality Control
• Quality Systems Managements
• Product design
• Supply Chain Management
• Post Market Surveillance
• Quality Systems
• Technical Management
• Operations and Engineering
• Compliance
• Executive Management
• Risk Management

Instructor Profile:

Chris Cook, PE, RAC, is a licensed professional engineer with over a decade of global regulatory affairs and quality experience. Mr. Cook is the Managing Director of 4Point Global Solutions, a consulting firm providing commercialization and compliance services to emerging and established medical device companies. Mr. Cook has as been responsible for regulatory affairs, quality, and compliance for multinational life-science corporations, such as Stryker Corporation, Straits Orthopaedics, and BIOTRONIK. He specializes in all areas of quality including assurance, control, and systems, Regulatory Submissions including 510(k), PMA, and MDD Technical Files, and compliance program development and management.

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