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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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November 27, 2013 |
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CfPA - The Center for Professional Advancement, New Brunswick, NJ
April 23-24, 2014
Who Should Attend
Participants who work in the medical device industry and who currently are or wish to sell their product in the US, Europe and other parts of the world will profit by attending this course. This includes professionals responsible for understanding and interpreting global regulations within their companies, in areas such as:
• Regulatory
• QA
• R&D
• Manufacturing
RAPS - Regulatory Affairs Professional Society This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Description
This course provides a detailed description of the current European and US quality system requirements for medical devices. With the continued growth in the development and acceptance of global standards, all device companies must stay up to date on the various regulations to ensure marketability of their products globally. The primary focus of this course is on the description of one quality system which complies with the ISO 13485 standard and the FDA Quality System Regulations and the documentation needed to support them.
Participant interaction, problem solving and open discussion will be strongly encouraged.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Bea Salis; Consultant, QualASyst International
Bea Salis has over a 25 year career in Regulatory and Quality Assurance for both drug and medical device companies. After working more than 18 years with various divisions for Baxter, she worked for startup new medical technology companies to help bring exciting products from the idea stage into clinical trials or preparation for marketing. Ms. Salis also has been instrumental in building startups into Wall Street traded companies. She has lectured widely in the US and abroad, and is now a full time consultant to the medical device industry. Her specialty is implementing, and compliance to regulatory and quality systems for both the US and Europe. Ms. Salis is an ASQ Certified Quality Engineer and a Certified Quality Auditor.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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