Best of Breed Risk Analysis Techniques for Medical Device Industry - Webinars

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Best of Breed Risk Analysis Techniques for Medical Device Industry Join expert panelists from TCS and MetricStream for an informative and practical webinar on Risk Analysis Techniques for Medical Device Industry

	Expert Panelists
	Rupam Chaudhury Global Industry Vertical Head - EIS Medical Devices and Pharma Mfg. Tata Consultancy Services
	Carl McCauley Vice President for Quality Management Solutions, MetricStream

Duration 1 hour

The first step in the risk management process is risk analysis. Risk analysis requires the definition of a device's intended use, characteristics related to safety, identification of known and foreseeable hazards and risk estimation for each hazard.

The webinar would help the medical device companies summarize the differences and relative strengths of risk analysis techniques most commonly used in the medical device industry, hence increasing the effectiveness of the risk analysis process. The speakers would describe following aspects of risk analysis and mitigation:

Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), Failure Mode & Effects Analysis (FMEA), Hazard and Operability Study (HAZOP) and Hazard Analysis and Critical Control Point (HACCP)
How the evolutionary process of Risk analysis is to be refined sequentially
How design details are elaborated and further data are acquired

Panelists
Rupam Chaudhury Global Industry Vertical Head - EIS Medical Devices and Pharma Mfg., Tata Consultancy Services Rupam has 15 years of experience in product development in Medical Device and Diagnostics companies. He pioneered the entry of TCS in the medical devices market about a decade ago and initiated, managed and grew several relationships in the USA, EU and UK. Rupam was also the original architect of the TeamCenter for Medical Devices, a DMR, DHF module which works on top of Siemens TeamCenter Engineering PLM software. Rupam has consulted companies on compliance readiness on Design Control, Complaints Handling, eDHR, Service strategies, launch and recall readiness on an over-all QMS and systems perspective. Rupam has created the bio-medical simulation competence in TCS with advanced simulation techniques, both predictive analytical and visual. His practice has created several unique product patents in Medical Devices over the years. He serves as the Industry Vertical Head for Medical Devices and Pharmaceutical Manufacturing for TCSs business within the Engineering and Industrial Services group.		Carl McCauley VP for Quality Management Solutions, MetricStream As the Vice President of Quality Management Solutions, Carl is responsible for meeting MetricStream's sales goals, managing customer relationships, and working with MetricStream's customers to identify areas where MetricStream's solutions can improve their business and add value to their operations. Most recently, Carl was the Chief Operating Officer of Visiprise, which acquired the manufacturing software group from Teradyne in January 2003. At Teradyne, Carl was the Vice President of Software Operations where he had P&L responsibility for developing and delivering manufacturing execution software to Fortune 500 manufacturers such as Celestica, Solectron, Hitachi, Sun, Compaq/HP, Raytheon, Goodrich, Philips Lighting, Textron, Ford, Chrysler and Abbott Labs. Prior to joining Teradyne in 2000, Carl was President and CEO of BrightPost Solutions, Senior Vice President of Product Management and Software Development at Fischer International Systems Corp, and Vice President of Software Applications at IVI Checkmate (formerly Checkmate Electronics). Carl has a Bachelor of Science degree in electrical engineering from the Georgia Institute of Technology.

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