Back ground of the topic:
Medical device recalls can cost billions. The number of medical device products affected by recalls have been increasing every year, exceeding 100 million units. This webinar not only teaches how to prevent recalls but also how to get high return on investment by finding very low cost solutions.
Why should you attend?
A critical and sometimes overlooked aspect of preventing medical device recalls is the inability to implement systems thinking. Systems thinking is not a panacea that can prevent every mistake, but it a best known tool that helps us predict hidden risks and help us see many robust solutions to eliminate risks. Unlike the limited single focused cause-and-effect approach, the systems thinking is about relatedness of individual causes to system causes, interdependencies on the knowledge of cross functional teams, interdependencies on the knowledge of manufacturers and device users, and understanding what you don’t know.
Description of the topic:
• Understand that FDA requirements are minimum requirements, we need to do lot more.
• Learn to write robust performance specifications
• Learn to form productive and innovative teams
• Avoid wrong practices in risk analysis
• Learn the best methods in risk analysis
• Conduct the design reviews to get high return on investment
• Learn to manage Verifications and Validations the right way
Areas Covered in the Session :
• INTRODUCTION TO MEDICAL DEVICE REQUIREMENTS
• PREVENTING RECALLS DURING SPECIFICATION WRITING
• RISK ASSESSMENT AND RISK MANAGEMENT
• PREVENTING RECALLS DURING EARLY DESIGN
• PREVENTING RECALLS DURING THE DETAIL DESIGN
• DESIGNING FOR PROGNOSTICS TO PROTECT PATIENTS
• DESIGN FOR HUMAN FACTORS IN USE
• PREVENTING RECALLS DURING PRODUCTION VALIDATION
• PREVENTING SOFTWARE DESIGN RECALLS
• PREVENTING SUPPLY CHAIN QUALITY DEFECTS
• PREVENTING RECALLS USING VERIFICATION PROCESS
• PREVENTING RECALLS USING DESIGN VALIDATION PROCESS
• RECALL PLANNING TO MAXIMIZE EFFICIENCY IN THE EVENT OF A RECALL
• ROLE OF MANAGEMENT IN PREVENTING RECALLS
• INNOVATION METHODS USEFUL IN PREVENTING RECALLS
Who will benefit:
All employees in R&D, Design
All employees in Manufacturing Engineering
Production Supervisors and Engineers
Quality Assurance staff
Product Safety staff
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls, Design for Reliability, and Assurance Technologies, is an international risk management, reliability, and system safety consultant for government, commercial and aerospace industry for over 30 years. His clients include Army, Navy, Air Force, NASA, Siemens, Eaton, Boeing, Lockheed, Northrup Grumman, General Motors, Prior to becoming a consultant in 1982 he worked at GE as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. He teaches Design for Reliability courses at the University of Maryland for degree programs in Mechanical Engineering and Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, and former chair of the Reliability Division. He is a Senior Member of IEEE. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. His served as Vice president of the International System Safety Society where he received the Scientific Achievement Award and the Educator-of-the-Year Award. He served on the Board of Directors for the Annual Reliability and Maintainability Symposium for more than 10 years.