VIEWS: 36 PAGES: 2 CATEGORY: Medicine POSTED ON: 1/4/2012
Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies.
Live Webinar on Product Risk Management Under ISO 14971 and FDA-ICH Q9 Date & Time: Wednesday, February 08, 2012 10:00 AM PST | 01:00 PM EST Register Now Duration: 90 Minutes Instructor: John E Lincoln Location: Online Price : $245.00 (for one participant) Instructor Profile: Overview: John E Lincoln Expectations for meaningful hazard analysis, hazardous conditions, Consultant, Medical device and documentation have always existed by regulatory agencies. and Regulatory Affairs There is an increased awareness of the importance of design John E. Lincoln is a medical device activities to support the production of safe and effective product. and regulatory affairs consultant. He Product risk management is a required tool to drive and direct has helped companies to implement resource constrained product design, manufacture and validation or modify their GMP systems and procedures, product risk activities in the company. High-profile field problems indicate that management, U.S. FDA responses. such activities are not yet adequately planned executed, and In addition, he has successfully visibility maintained. There is a failure to fully utilize the power of designed, written and run all types of current risk management tools. Effective use of such risk process, equipment and software management tools can help address the growing push by the public qualifications/validations, which have and the FDA, to "toughen" its approach to product clearance and passed FDA audit or submission approval, while reducing liability issues. scrutiny, and described in peer- reviewed technical articles, and workshops, world wide. John has Areas Covered in the Session: also managed pilot production, regulatory affairs, product development/design control, 510(k) l The Revised ISO 14971:2007/9 for Devices submissions, risk management per l ICH Q9 for Pharma ISO 14971, and projects; with over l Product Hazard Analysis 28 years of experience in the FDA- l Design, Process, and Use[r] Failure Mode, Effects and Criticality regulated medical products industry Analysis - working with start-ups to Fortune l Fault Tree Analysis 100 companies, including Abbott l Suggested Risk Management File / Report, FMECA, FTA Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate Templates of UCLA. ...more l The Team and It's Involvement – Who, When and How l Using the Completed Document – It's Real Value "In the Loop" Click here to register for this webinar Suggest a Topic More Webinars Your Necessity is our Priority Who Will Benefit: l Senior Management in Drugs, Devices, Biologics, Dietary Supplements l QA l RA l R&D l Engineering l Production l Operations l Consultants; others tasked with project leadership responsibilities It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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