10/8 Agensys Program: Establishing a Quality Risk Management System(QRM) for Drug Development

Establishing a Quality Risk Management System (QRM) for Drug Development


Thursday, October 8, 2015
5:45 pm- 8:00 pm  (Speakers begin at 6:30)

Agensys, Inc.

1800 Stewart Street
Santa Monica, CA
David Steinberg, Director, Engineering & Facilities, Agensys, Inc    
Program Manager:
Paul Crissman, Principal, Biotechnical Solutions    
Bikash Chatterjee, President and CSO , Pharmatech Associates
Quality Risk Management (QRM) principles require the evaluation of risk to quality based on scientific knowledge and the protection of the patient. Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS) by using both formal and informal risk tools based on ICHQ9. The application and the complexity of risk management tools need to be appropriate to the timing of the risk event, the level of risk and the elements of the QMS under scrutiny. This presentation will utilize Pharmatech’s case studies as a basis to discuss the key activities within the product development lifecycle where risk management can be most impactful along with potential tools and systems for monitoring QRM as part of an overall knowledge management program.

Register Here


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