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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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February 12, 2008 |
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The Center for Professional Advancement, Amsterdam, The Netherlands
16-17 June 2008
Who Should Attend
This course is designed for those who work in the medical device industry and who currently are or wish to design and sell their products in US, Europe and other parts of the world. This includes, but is not limited to those in the following functions:- R&D and Quality Engineering
- QA or Regulatory
- Engineering and Manufacturing
All participants will gain tools to incorporate risk analysis throughout the quality system in compliance with global regulations and to ensure safe devices. Description
This course will review the current regulations and expectations for the use of risk management processes and methods in the life cycle of medical devices. We will discuss the use of the ISO 14971:2000 standard and FDA’s guidance documents on Human Factors Engineering to provide a clear understanding of what techniques to use and when they should be implemented. Practical workshop activities will provide guidance on how customer use and potential misuse information can be acquired and used, as well as actual performance of various risk analysis techniques. The course will also provide guidance on what type of risk analysis should be performed at each phase of the medical device history, from early design concepts through use in the field.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Bea Salis; Consultant, QualASyst International
Bea Salis has had 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 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. She 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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info@cfpa.com
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