Revamping Risk Management – A Renewed Imperative -Sharad Narayan-09/28/2010 - 8:30am

Event Information
Event Topic: 
Revamping Risk Management – A Renewed Imperative
Event Date: 
09/28/2010 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Speaker Information
Event Speaker: 
Sharad Narayan
Event Speaker Title: 
Manager, Health Care
Event Speaker Company: 
PRTM Management Consultants
Event Speaker Bio: 

Sharad Narayan is a Manager in the Healthcare practice of PRTM Management Consultants, a leading operational strategy consultancy. His current focus is on Quality Systems effectiveness in Medical Device and Biopharmaceutical firms. Sharad has a background spanning product and process development, capital asset management, and supply chain management in the MD&D and Biopharmaceutical industries.

Prior to PRTM, Sharad served as an engineering manager with a specialty drug delivery company, overseeing R&D as well as manufacturing of target-specific inhalation aerosol products. After joining PRTM, Sharad has worked with Biopharmaceutical and MD&D clients to develop, remediate, and implement Quality Systems, and to prepare for regulatory inspections. Beyond the Quality and Regulatory arena, Sharad has worked with firms to identify EBITDA improvement opportunities, pilot capital asset project management processes, redesign inventory control systems and develop clinical development cycle-time benchmarks.

Sharad received his Master of Business Administration from the UCLA Anderson School of Management and a Bachelor of Science in chemical engineering from the University of California, Berkeley. He has worked at firms and clients in Asia, Europe, and North America. Sharad is Certified in Production and Inventory Management (CPIM) by APICS.

Event Details
Cost: 
$0
Event Details: 

The bar for risk management has suddenly moved higher for medical device companies. After numerous product-safety-related recalls and field actions over the past few years, the Food and Drug Administration (FDA) has dramatically increased its scrutiny of product risk management practices, demanding adherence to the current standard, ISO 14971:2007. With the agency now examining risks in terms of the worst possible outcome, practices that had been presumed acceptable are subject to heightened scrutiny.

This session will cover some of the changes in thinking at FDA, and how firms and individual contributors can and ought think about risk management in the new environment. We will offer a perspective on the what, who, how, when and where of risk management throughout the product life cycle.