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CfPA-The Center for Professional Advancement, Chicago, IL
August 15-16, 2016
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. Course Description
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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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| Helen Chandler; Quality/Regulatory Consultant |
Helen Chandler has over 27 years of professional experience in quality engineering, quality assurance and regulatory compliance for the pharmaceutical, IVD, and medical device healthcare industries.
Ms. Chandler has acted as both senior manager of quality and as a consultant for Medical Device Quality System Regulation (QSR), ISO 9001, ISO 13485, and MDD 93/42 EEC in the following areas: quality engineering, supplier quality engineering, auditing, sterilization, environmental control, calibration, incoming quality assurance, and corrective/preventive action. Her experience also includes quality and process engineering for In-Vitro Diagnostics and Pharmaceuticals. She has specialized in process optimization and validation (including test method development) for both automated and non-automated processes. This includes extensive experience in large ERP system software validation.
She has been the quality representative and a quality/regulatory consultant on numerous design control teams. As such, she has acted as project leader, led teams in risk management, and participated new product non-clinical validation activities. She is an experienced trainer in quality systems, process and software validation, statistical techniques, and team building. She has performed numerous audits internally, third party and with suppliers.
Ms. Chandler has a B.S. in Chemical Engineering, and a B.S. in Biology. She is a Certified Quality Engineer 1993 – present (CQE-ASQ), and was Regulatory Affairs Certified 2001-2007 (RAPS). She is a member of American Society for Quality (ASQ), Regulatory Affairs Professional Society (RAPS), and North Carolina Regulatory Affairs Forum (NCRAF).
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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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jmorbit@cfpa.com
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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.