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2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare
Link to Website
Ticket Price: Price - Seminar One Registration - $ 1395 Special Group Discount Register for Four attendees - $ 3885
DescriptionThis is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
- FDA’s Inspectional Authority and History
- FDA Inspection Program Overview
- Key factors for a successful FDA inspection
- Quality System Readiness
- Organization Readiness
- Manage Inspection Outcomes
- Information and Documentation
- How a firm should prepare for an FDA inspection?
Who will Benefit
- Executive Management
- Regulatory Affairs Management
- Regulatory Affairs Specialist
- Compliance Officer
- Compliance Specialist
This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities.
David R DillsRegulatory Affairs & Compliance Consultant
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
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