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Design Control and Product Validation

  July 06, 2017  
CfPA-The Center for Professional Advancement, Chicago, IL
October 12-13, 2017

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
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.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
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).


 Michele Vovolka, President, Vantage Consulting International, Ltd.

Michele Vovolka, is the President of Vantage Consulting International, Ltd. She has over 27 years of quality, regulatory, customer service and project management experience with various divisions of Baxter Healthcare and Allegiance Healthcare. 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 Notifications (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 including the first Russian GMP compliant and ISO certified manufacturing operation. She has been directly responsible for the implementation of design control processes that resulted in the market introduction of over 850 new products within an 18-month period. Ms. Vovolka has a B.S. degree in Biochemistry and Chemistry. She is an ASQC Certified Quality Engineer and Certified Quality Auditor, and is also Regulatory Affairs Certified, (RAPS). She is a member of American Society of Quality Control, Regulatory Affairs Professional Society.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
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