Global Compliance Trainings, 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
03-03-2014
Webinar Description :
The ISO 12971 standard on risk management for medical devices describes risk analysis tools such as PHA, FTA, FMEA, HAZOP, and HACCP but does not provide the depth needed to use the tools correctly. These tools are therefore often misused or used incorrectly, or not used at all. That is why there are almost 900 device recalls a year. This webinar will take you to the depth needed with best practice examples from medical device and other industries.
Areas Covered:
INTRODUCTION TO ISO 14971
RISK ANALYSIS PROCESS
PRELIMINARY HAZARD ANALYSIS (PHA) FAULT TREE ANALYSIS (FTA) FAILURE MODE AND EFFECTS ANALYSIS HAZOP (HAZARD AND OPERABILITY) ANALYSIS HAZARD ANALYSIS AND CRITICAL POINT CONTROL (HACCP) ANALYSIS Why you should attend: This Webinar is about preventing safety defects instead of finding defects one at a time after thousands of devices are sold. The product price cost should be lower because of no warranty costs and no product recall costs. Who will benefit: This webinar offers very critical knowledge design engineers and manufacturing engineers on how to design and produce the best product in the market. Senior management should be particularly knowledgeable to provide leadership in providing resources during early design and to provide a sound structure for product development and R&D excellence. All engineers and all managers will find this webinar of immense use. Quality Assurance staff and regulatory staff will benefit very significantly. Instructor Profile Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, UK, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to becoming a consultant in 1982 he worked at GE healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen & Hamilton as Risk Management consultant for nuclear and mass transportation industry Live Session for one participant Price: $225.00 Corporate Live Session 4 to 10 participants in single location. Price:$885.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $275.00
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