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CfPA - The Center for Professional Advancement, New Brunswick, NJ
February 1, 2012
Who Should Attend
This one-day course is designed for those who perform, supervise, manage, audit, or oversee purchasing controls activities for medical device companies. This includes, but is not limited to, professionals in:
• Supplier Quality
• Supply Chain Management
• Supplier Quality Assurance
• Current suppliers (for both products and services)
• Those wishing to become suppliers to medical device
companies Description
This intensive, one-day course provides comprehensive and up-to-date knowledge of purchasing controls for quality assurance and control of purchased components, services, or finished medical devices. The course covers regulatory expectations regarding purchasing controls as contained in U.S. and International regulations and guidelines. The Global Harmonization Task Force (GHTF) guideline GHTF/SG3/N17:2008–Quality management system– Medical devices–Guidance on the control of products and services obtained from suppliers will receive special attention and coverage. This course will prepare attendees to effectively manage the Purchasing Controls process.
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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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John Freije; President and Principal Consultant, Freije Quality Engineering, LLC
John Freije works with medical device companies and their suppliers to develop and implement Quality Systems that exceed the expectation of ISO 13485 and FDA's Quality System Regulation 21 CFR 820.
Mr. Freije has over 28 years experience working for the government and the private sector, with 18 years in the medical device and pharmaceutical industry. Experience includes working in quality systems at Roche Diagnostics as a Quality Systems Principal, Product Assurance Manager for Raytheon Technical Services Company involving projects for the Special Forces and Direct Fire Control, Engineering and Quality positions at Eli Lilly and Company focusing on bulk manufacturing for injectables and dry products manufacturing for clinical trials, medical device commercialization and manufacturing. He served eight years in the Ordnance Corps in the US Army as a Systems Mechanic.
Mr. Freije received his Masters of Science in Engineering from the University of Wisconsin and completed his undergraduate studies at Purdue University. He is a senior member of the American Society for Quality (ASQ) where he is a Member Leader in the Biomedical Division and active with the Society of Manufacturing Engineers (SME). Mr. Freije is also an ASQ Certified Quality Engineer and a SME Certified Manufacturing Technologist.
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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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