Do's and Don'ts during FDA Inspections

03:00 PM ET | 12:00 PM PT | 04:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"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"

How to change and improve your ways of preparing for and getting ready for an FDA inspection

Description

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.

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.

Areas Covered

•      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

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

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff 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 received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Jeff Kasoff, RAC, CMQ/OE 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 start-up 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.

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