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The Center for Professional Advancement, Amsterdam, The Netherlands
19-20 June 2008
Who Should Attend
This course is intended for personnel who are responsible for medical device design and development such as- Engineers
- Scientists
- Project Leaders
- Technical Managers
- Senior Technicians
- Department Heads
Quality Assurance, Compliance and Regulatory personnel will also benefit because of their responsibility for implementation, validation and evaluation of design controls as part of the overall quality system. Sales and Marketing personnel will learn their vital roles in providing input to the design process and requirements for design changes. Description
The course describes how to establish and implement a system for design controls for various classes of medical devices for both the U.S and Europe. It also provides guidance to assist manufacturers in knowing when controls are required. The underlying concepts will be explained in practical terms and exercises will be used to promote understanding. Sample procedures and forms will be provided in both hard copy and computer disc format.
Emphasis will be on understanding the requirements and providing tools to assist in management of the design control process. The course will discuss each phase of the design process and explain the terms: design input, design output, design review, verification, validation, and design history file. Particular emphasis will be given to understanding the difference between design verification vs. design validation, and describing activities relative to validating a product design. Also discussed will be FDA's inspection strategy and how to manage a successful audit for design controls.
You will return to the workplace with new tools to apply an effective project management approach to your design control process which will ultimately reduce time to get to market, reduce development cost, and ensure regulatory compliance.
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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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Jan Miller; Quality Systems Consultants, Vantage Consulting International, Ltd.
Jan Miller, a Quality Systems Consultant, has over twenty-five years experience in the U.S. and International Healthcare industry. She has directed responsibilities in Medical Device Quality System Requirements (QSR), Design Control, Medical Device Reporting, Recall and Field Corrective Actions, Good Laboratory Practices, Premarket Notification (510k), European Technical File, New Drug Applications, Investigational Device Exemptions, and Quality Audits at various divisions of Baxter Healthcare and Allegiance Healthcare. She assisted with the implementation of cGMP/ISO quality systems for the first company inside Russia to obtain ISO certification. Ms. Miller has a B.A. in Business Management. She is Regulatory Affairs Certified (RAPS) and is a Certified International Quality Assurance Lead Assessor (IQA). She is a member of The American Society of Quality (ASQ), and Regulatory Affairs Professional Society (RAPS).
Michele Vovolka; Quality Systems Consultants, Vantage Consulting International, Ltd.
Michele Vovolka is a consultant specializing in the implementation of project management and quality systems. Ms. Vovolka has over fifteen years of quality, regulatory, customer service and project management experience in the pharmaceutical and medical device industry. She has directed responsibilities in Medical Device Quality System Requirements (QSR), Design Control, Medical Device Reporting, Recall and Field Corrective Actions, Good Laboratory Practices, Premarket Notification (510k), European Technical File, New Drug Applications, Investigational Device Exemptions, Quality Audits, Program Management and Customer Service Operations. She has been directly responsible for the implementation of multiple quality systems which resulted in the market introduction of over 700 new products within an eighteen month period. Ms. Vovolka has a B.S. degree in Biochemistry and Chemistry. She is an ASQ Certified Quality Engineer and Certified Quality Auditor and is also Regulatory Affairs Certified (RAPS). She is a member of the American Society for Quality (ASQ), Regulatory Affairs Professional Society (RAPS), and the National Association for the Education of Young Children.
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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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