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Class offered: February 10, 2009 Michaels at Shoreline, Mountain View, CA |
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Quality Systems for Medical Devices: QSR and ISO13485
This class provides attendees with a detailed view of quality systems for design, develop, manufacture and test of medical devices under the ISO quality management system standard and the Quality System Regulation. Attendees will learn the elements of GMP as well as compliance strategies which conform to FDA, Canadian (CMDR), European (MDD), Japanese and other international regulatory expectations.
Topics covered include:
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History and Purpose of the QSR and ISO 13485 standards |
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FDA and ISO and their roles in international regulatory approval and compliance including The Global Harmonization Task Force (GHTF) |
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A Walk through the Standards including: |
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- Management responsibility |
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- Quality Manuals and Document Controls |
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- Design and Development Documentation |
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- Quality Control and Statistical Process Control\ - Nonconformances and CAPA |
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- Special requirements for sterilized products |
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Documentation required by regulations |
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The FDA approval process and ISO registration process |
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Maintenance of systems and CAPA |
Intended Audience: This is a fun and interactive class designed to familiarize attendees with the standards being discussed through numerous examples and interactive exercises. Recommended for all levels of personnel.
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Class offered: February 10, 2009 Michaels at Shoreline, Mountain View, CA |
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