The FDA Inspection Process: From SOP to 483
Duration : 60 Minutes
Jeff Kasoff,
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, 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 unique Read more
This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Course Objectives:
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional – you are in charge of compliance, usually in the background and now you are in the spotlight and if your performance isn’t good, it’s not the show that may close, it’s your company! However, adequate planning, training, composure, and understanding should result in many encore presentations! 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.
Course Outline:
• How to prepare for an FDA inspection
• Development and contents of an SOP for FDA inspection
• Personnel training before inspection
• How to behave during an inspection
• Limitations of the scope of an inspection
• Response to investigation findings
• FDA guidance documents used by their inspectors
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
• Executive/senior management
• Regulatory management
• QA management
• Any person who may have direct interaction with FDA officials
• Consultants
• Quality system auditors
• Quality Engineers
• Compliance Specialists
• Compliance Leaders
• CAPA Specialists
• Management Representatives
• Compliance Managers and Directors
• Quality Managers and Directors
• Consultants and Contractors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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