$198 – $399

Preparing for an FDA Medical Device Sponsor Inspection Live Webinar

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Live Webinar Preparing for an FDA Medical Device Sponsor Inspection

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

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


Overview

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.


Session Highlights

- 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


    Instructor Profile

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview .



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