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Design Control for Medical Device Professionals

  February 11, 2016  
Center for Professional Innovation & Education, Inc., Los Angeles, CA
April 11 & 12, 2016

This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines.

Among the topics to be discussed are: context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Organized by: Center for Professional Innovation & Education
Invited Speakers:

Jim Rosa is the VP of QA/QE Consulting at Dohmen Life Science Services (DLSS) a consultancy for the Medtech, BioPharma, and Biologics industries. Mr. Rosa consults in technical, quality and regulatory aspects of medical products. Mr. Rosa’s group engages with more than 50 companies on an annual basis for support in Medical Device Development efforts.

Mr. Rosa has 40 years of experience of leading advanced development R&D groups and Quality Implementations within regulated industries with novel and practical solutions. Mr. Rosa’s experience includes: Quality and Regulatory Consulting; CeMines Inc.: President and COO - an IVD company which successfully transferred lung cancer markers to Ortho-Clinical Diagnostics, a Johnson & Johnson Company; Intel Corporation: Capability Lead for wireless personalization technology and integration of WLAN and 3G technologies within Intel Architecture Laboratories, Director of Technology Transfer/Global Engineering Projects at Gambro Renal Care, responsible for the technology convergence within different divisions to support multiple markets; Adjunct Instructor at CSU in the biomedical engineering program for Design Controls and Risk; and the U.S. Navy.

The blend of working within research & development and quality systems functions, in Europe and the US, and with startups thru Fortune 50 companies provides a unique insight in the practical application of quality systems to medical devices. Mr. Rosa has multiple patents related to medical device safety system implementations and recently received the Colorado BioSciences Association’s (CBSA) Institute Leadership Award for advancing the Workforce Training and Development programs for the Colorado Biotech/Device industry.

Mr. Rosa has earned degrees from Colorado State University (MBA) and the Radford University (BSCS).

Deadline for Abstracts: n/a
E-mail: info@cfpie.com
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