Details 
#612 Design Control
Content: This course focusing on the Quality System Regulation will provide a practical understanding of medical device Design Control. It includes:
• 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 ISO 13485:2003.
• You will create a list of design activities during a workshop, then fit them into the design control stages of Concept, Development, Design Verification, Design Validation and Design Transfer.
§ 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.
• This course will have several mini-workshops, in several phases as mock medical device concepts will be taken through the complete design control process.
Course Hours: 8am to 12pm, 1pm to 5pm. 8 hours
Instructor Bio:
Barrett C. Craner, was 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.
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 Past 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).
Email: bcraner@gmail.com
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