B110 - Risk Management & Analysis

Overview

Provides a workshop type setting in which the major risk identification and risk reducing methods will be characterized. Summary and introduction of issues the FDA and Europe faced early on that moved them towards the focus of requiring risk management in all aspects of product development and manufacturing. The EN/ISO 14971:2012 will be featured, however, its requirements parallel those of all major risk management standards and will be useful in all industries.
The seminar includes detailed discussion and workshops for several key risk management tools:

• Risk Management Planning

• Risk Management file

• Hazard Analysis (ID product and process hazards - determine level of risk)

• Fault Tree Analysis - FTA - Product/Design

• Fault Tree Analysis - FTA - Process

• Failure Modes and Effects Analysis (FMEA) Product/Design

• Failure Modes and Effects Analysis (FMEA) Process

• Failure Modes and Effects Analysis (FMEA) Use/Application

Hazard Analysis & Critical COntrol Point Analysis - HACCP Analysis
Reducing (mitigating and controlling) risk
Review & explanation of standards relevant to medical device risk management
Workshop are performed in class for practical experience - as time permits
Other industrial sectors (Aerospace, Defense, Space, Pharmaceutical...) will be represented in part to show the wide application of these tools
CD with several public domain resources

Instructor Barry Craner

Instructor Bio

Barry Craner is retired from industry (formerly Vice President QA/RA, Stellartech Research Corporation), but continues to lecture and consult.
Education/Certifications: Barry holds two masters degrees, four certifications from ASQ, is RAC (RAPS), and served on the White-House Council on Y2K (Medical Devices).
Management Fields: During his 40 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 has been active in the ASQ Biomedical Division for 30 years, having served three times as Chair of the Northern California Biomedical Discussion Group, as Past Chair of the ASQ Biomedical Division, and of the San Diego Section of ASQ.
Teaching: Currently teaches for the Silicon Valley Section, three classes in medical device quality assurance technologies: Risk Management, Design Control, and Auditing. As a Professor, Barry continues to teach a graduate semester class since 2007 in Risk Management in the Masters in Quality Assurance Program at the California State University, Dominguez Hills. And, Since 2009, he has been an Instructor at the University of California Santa Cruz Extension, teaching Risk Management in certification programs in Medical Devices and Regulatory Affairs.
Honors: Barry is a Fellow of the American Society for Quality, was honored in 2008 by ASQLA with the Simon Collier Quality Award, in early 2010 with the ASQ Marvin Rosenbaum Distinguished Service Award, and in November that year, with the Stanley Marash Scholarship to speak at the International Quality Congress in Tel Aviv, Israel. In 2015, Barry was honored by the ASQ Biomedical Division naming a scholarship (Barrett C. Craner Scholarship) for Quality Assurance professionals desiring to follow advanced academic pursuits in the QA field.

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Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.

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Course Details

Prerequisites: Basic familiarity with FDA regulations

Hardware: N/A | Software: N/A

Required Materials:

- Proof of online Payment

- Pencil & Paper or laptop/tablet if you prefer

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

Learning Method: Lectures, teams, case studies, hands on approach, class discussions and examples

Class Time: 8 hours

Class Size: 25 max. participants

Facilities: Room with PC projector, whiteboard, etc.

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