Details 
Risk Management Course Content:
This course will provide a work-shop setting in which the major risk-identification and risk-reducing methods will be characterized: Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis - FTA, Hazard and Critical Control Point Analysis - HACCP Analysis will be performed real-time in class in order to experience practical implementation of these processes. Examples will be worked on in class Identifying product and process hazards, Evaluating the hazards for possible level of risk, Ways to creatively brainstorm on reducing (mitigating) the risk. Summary and introduction of the issues facing the FDA and Europe early on, which moved them toward the focus of requiring risk management in all aspects of product development and manufacturing, including mechanical, electrical, software, and disposable products. Full, usable procedures on Risk Management, Fault Tree Analysis, and Failure Modes and Effects Analysis CD with 60 public and original resources for Risk Management in medical devices Binder with over 100 pages of material, including all class presentation notes, procedures, worksheets, etc.
Learning Objectives:
• How to adapt many of these skills and processes for your specific needs, in or out of the medical device development and manufacturing environments.
• How to implement both predictive and preventive processes.
The course will also review recently enacted standards relevant to medical device risk management and explain the applicability of these analytical processes to the product development cycle
Course Prerequisites: Basic familiarity with FDA regulations
Course Hours: 8 hours, 8am to 12pm, 1pm to 5pm
Instructor Bio: Barrett C. Craner, was most recently 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).
Email: bcraner@gmail.com
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