Preparing for an FDA Medical Device Sponsor Inspection

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear From Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries"

New product-marketing approvals

Description

In the regulated medical device industries, inspections by government agencies are often a prerequisite for new product-marketing approvals. Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. As the FDA and other regulatory authorities increase the frequency of inspections, it is imperative that everyone involved in the development of new therapies be familiar with government inspection processes and their role during these inspections.

Areas Covered

•        Device sponsor inspections
•        Pre-inspection process
•        FDA inspection preparation
•        Inspection day
•        What does the FDA inspect?
•        Inspection conclusion
•        Common sponsor deficiencies
•        Post inspection process
•        Inspection classification
•        Written response
•        Points to consider
•        Summary

Who will Benefit

•        Quality Managers
•        Quality Engineers
•        Regulatory Affairs
•        Small business owners
•        GxP
•        Consultants
•        Quality VPs
•        IT VPs
•        FDA investigators
•        Other regulatory agency investigators

 

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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