ASQ Silicon Valley Biomedical Class: Design Control Requirements December 13, 2008

Instructor: Barry Craner
Location: TBD (Registered students will be given directions to the classroom, usually two to three days before the class. Most likely, the class will be in San Jose or Santa Clara.)
11. Course #612: Design Control Requirements
This course focusing on the Quality System Regulation will provide a practical understanding of medical device Design Control, with:
· A discussion of the regulatory requirements for design control, and why the FDA and Notified Bodies require it.
· A comparison will be made between the design control requirements of ISO9001:2000, 21CFR820 and the new 13485:2003.
· You will create a list of design activities during a workshop, then fit them into the design control stages:
o Concept phase (design Input), before development starts, then the
o Development phase, which includes Design Output, Design Control of documents produced during the development phase,
o Design Verification (assurance that the device was designed according to the Design Input, and each phase output matches the requirements of the previous phase),
o Design Validation (assurance that the device was actually what the customer base wanted), and finally
o Design Transfer (assurance that all design phases were completed, along with all remaining action items), and
o Discussion of the Design History File, Dossier, and Technical File.
· Elements of Risk Management and Human Factors, now required in all design phases will be briefly discussed.
· A discussion of pro’s and con’s of Contract Design and how to manage it, from the twinkling of an eye to completion.
· A brief discussion of how the FDA sees design control from an auditing standpoint (QSIT).
· A description of the concept and use of a Trace Matrix, to make your life easier during the design project.
· Template SOP’s for all phases of design control will be presented as resources.
· A CD with more than 30 public domain and created references for design control helps and discussion.
· A Binder with almost 200 pages of materials to be used in and out of the class.
· This course will have several mini-workshops, in several phases as mock medical device concepts will be taken through the complete design control process.
Instructor: Barry Craner
Barrett C. Craner, is Director, Quality Assurance for Lipid Science, Inc, a company engaged in the research and development of products to treat major medical indications in which lipid component plays a key role.
Education/Certifications: Barry holds two masters degrees, four certifications from ASQ, and served on the White-House Council on Y2K (Medical Devices).
Management, Fields: During his 30 year career in domestic and international management of engineers and scientists he has engaged in various senior, principal and management roles in engineering, quality assurance, in several firms in the medical device, aerospace and Information Technology arenas.
Papers, Publications: He has delivered more than 50 papers and seminars to a wide variety of audiences and locales in areas of science, quality assurance, and regulatory issues, and has various trade journal, proceedings, and symposia publications.
Auditing: He has performed many 1st, 2nd and third party audits of medical device firms and suppliers.
Professional Activities: He is active in the ASQ Biomedical Division, having served as Co-Chair of the Northern California Biomedical Discussion Group, and currently as Chair of the ASQ Biomedical Division.
Teaching: Currently teaches three classes in medical device quality assurance technologies: Risk Management, Design Control, and Auditing, and a graduate semester class in Risk Management in the Masters in Quality Assurance Program at the California State University, Dominguez Hills.
Honors: Barry is a Fellow of the American Society for Quality, and is RAC (RAPS).
Please note new registration instructions: To register for this class, complete the registration form below, including credit card information, and FAX it to Jim Bischof. (Please notify me if you would like to be dropped from my mailing list.)
If paying by check, make check out to ASQ, and mail immediately to Jim Bischof, 5666 Keymar Drive, San Jose, CA, along with the completed registration form.
If you have questions about registration, (or you would like to host this class at your company) contact Jim Bischof 408-972-8852 or [email protected]
Biomedical Class
Course Registration Form
(Please use one registration form for each class you register for. FAX this completed form to 1-408-362-9083. The class coordinator will provide you confirmation that you are registered.)
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