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Medical Device Quality Regulations
This course has been designed to help you understand the requirements of FDA regulations and focuses on regulatory requirements specific to Medical Devices.
Although specific to Medical Devices, this course is also helpful to Pharma and Biologic firms to understand how FDA is applying the Quality System Regulation to their industries.
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Our training will include: |
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What are QS Regulations
The FDA Philosophy
Medical Device Overview
Relationship to ISO standards
Relationship to ISO standards
The Quality System Regulations
Quality Records
Regulatory Requirements and FDA expectations
Impact of QS Regulations on other industries
The Quality System Inspection Technique
Design Controls
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Instructor, Jeff. Boatman is a recognized industry leader in the invention and implementation of medical devices, manufacturing processes, and test methodologies. Mr. Boatman has worked in virtually every aspect of Medical Device engineering, from laboratory supervisor, manufacturing engineer, R&D, and quality and compliance management.
Come find out just how much you could be saving!
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Clear your calendar and mark the date! |
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DATE: October 16,17, 2008
Location: Best Western Royal Plaza
Marlborough, MA
Time: 9:00 am to 5:00 pm
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