Compliance Trainings, Online
2015-03-11
Description : 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, and satisfy U.S. FDA cGMP and CE-marking / Notified Body expectations. 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 for Devices (with ALARP discussion) ICH Q9 for Pharma Product Hazard Analysis Fault Tree Analysis Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis Suggested Risk Management File / Report, FMECA, FTA Templates Why and How to use the ISO 14971 "Model" in all Regulated Industries The Team and It's Involvement – Who, When and How Using the Completed Document – It's Real Value “In the Loop” Q & A session Who Will Benefit: The employees who will benefit include: Senior management Middle management R&D Engineering Software QA / RA Manufacturing Operators Consultants cGMP instructors And all personnel involved in verification and/or validation planning, execution and documentation. Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
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