B112 - Design Control Requirements & Process Validation

Overview

This course focusing on the Quality System Regulation and the European QMS standard 13485 will provide a practical understanding of medical device Design Control, with workshops in creating documents for the various stages of design, through release to manufacturing, and to buyers and users. The FDA 21CFR 820.30 Quality System Regulation – Design Control will be reviewed to assure the domestic regulation is understood regarding design review requirements. The international Quality Systems Standard “ANSI/AAMI/ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes” will be reviewed with a focus on international requirements for “product realization”. We will develop checklists in class for several of the phases of design control. This course will have several mini-workshops, one in each phase as mock medical device concepts will be taken through the complete design control process.

The seminar includes detailed discussion and workshops for several key Design Control tools:

� FDA 21CFR 820.30 Quality System Regulation – Design Control
� ISO 13485:2003 Medical devices - Quality mgt systems - Requirements for regulatory purposes
� ISO 14971:2000 Risk Management for medical devices
� Design Planning
� Design Input
� Design Output
� Design Control
� Design Verification
� Design Validation
� Design Transfer
� Design History File

� Technical File
� Example procedures
� Multi-faceted Case Studies
� Workshops

� CD with several public domain regulations, resources.

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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: Participants are expected to be familiar with basic 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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