Date : Wednesday, June 22, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 90 Minutes Price : $245.00
Live Webinar Developing and Using the Product Risk Management File/Report
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: l l l l
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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"
Instructor Profile: John E Lincoln Consultant, Medical device and Regulatory Affairs 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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peerreviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDAregulated medical products industry working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
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Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Consultants; others tasked with project leadership responsibilities
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