Online Seminar 2019 - Do's and Don'ts during FDA Inspections

Overview
This webinar will provide useful and practical information for you to consider and implement for your organization, significantly contributing to hosting successful FDA inspections. At the end of the webinar, you will learn what and how to change and improve your ways of preparing for and getting ready for an FDA inspection.
Objectives of the Presentation
How to prepare for an FDA inspection
Development and content of an SOP for FDA inspection
Personnel training before inspection
How to behave during an inspection
What to show FDA during an inspection
Proper Post-inspection Follow-up
Limitations and scope of inspection
Response to investigation findings
FDA guidance documents used by their inspectors
Why Should you Attend
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and now you're 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 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. 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.
Who will Benefit
Internal / External Auditors
Regulatory Management
Quality Assurance Professionals
Consultants
Sales/Marketing Management
Senior and mid-level Management
QA/QC
Compliance
Regulatory Affairs
Operations and Manufacturing
Instructor Profile
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.