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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training/In Conjunction with Medical Device Summit
January 25, 2011 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online 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) and those wishing to become suppliers to medical device companies. Description
This 90-minute accredited online training 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 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.
Module 1: Introduction
• Terms and Definitions
• FDA and ISO Regulations Pertaining to Purchasing
Controls and their Differences
• Overview of Warning Letters
• Why do I Need a Purchasing Controls Process?
Module 2: Supplier Selection Process
• Process Flow Overview
• Using Risk in Selection of Suppliers
• Cross Functional Team Approach
• Supplier Selection Activities
• Contracts/Agreements with Suppliers
Module 3: Supplier Monitoring/ Certification Process
• Acceptance Activities
• Approved Supplier List
• Tiered Approach to Supplier Certification
• Periodic Supplier Quality Evaluation
Question and Answer Session
About Medical Device Summit
Medical Device Summit publishes news, technology, trends, regulations, and opinions, as well as offers educational, career advancement and networking opportunities to the global medical device and diagnostics industry. This information exchange is facilitated through ePublishing, digital and live events. By providing such an exchange of knowledge and technologies, MedicalDeviceSummit hopes to help advance the progress of the global medical device and diagnostic industry, thus, contributing to a healthier world.
MedicalDeviceSummit.com is an online meeting place and industry specific web site for the global medical device industry. The content is a mix of journalistic-style articles, technical articles, blogs, white papers, press releases and news.
For more information visit their website atwww.medicaldevicesummit.com or email rbiros@InnovativePublishing.net.
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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 of 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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