This seminar will focus on addressing these concerns and educating participants on FDA recent medical device software regulation strategies. Seminar instructor Casper Uldriks is an ex-FDA official who has spent 32 years with the FDA. His engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to FDA requirements.

Date : 21st September 2017 to 22nd September 2017

Place : United States, Boston

Website :https://www.eventbrite.com/e/fdas-medical-device-software-regulation-strategy-com-tickets-33512784641?aff=NDT

Contact Person:Paula Edwards

Description:

This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies. Seminar instructor Casper Uldriks is an ex-FDA official who has spent 32 years with the FDA. His engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to FDA’s requirements.

This seminar will focus on addressing these concerns and educating participants on FDA recent medical device software regulation strategies. Seminar instructor Casper Uldriks is an ex-FDA official who has spent 32 years with the FDA. His engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to FDA requirements. will be held in Boston,United States on date 2017-09-22

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Deadline for abstracts/proposals : 1st September 2017

Keynote Speakers : Casper (Cap) Uldriks Former Associate Center Director of FDA's CDRH Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health

Conference Highlights :Learning Objectives: Understanding FDA legal authority Applying FDA classifications / risk controls Understanding FDA and NIST software guidance Identifying the quality system regulation for risk management, software verification and validation

Venue :Boston, MA, United States

Check the event website for more details.