Risk Management 2015 - Developing and Using the Product Risk Management File & Report

Overview:
Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies.
There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues.
Why you should attend: The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document".
Areas Covered in the Session:
The Revised ISO 14971:2007 for Devices
ICH Q9 for Pharma
Product Hazard Analysis
Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
Fault Tree Analysis
Suggested Risk Management File / Report, FMECA, FTA Templates
The Team and Its Involvement - Who, When and How
Using the Completed Document - It's Real Value "In the Loop"
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants; others tasked with project leadership responsibilities
Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
Event Link: http://bit.ly/1CGKGfO
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www.compliance4all.com