Compliance Trainings, Online
2015-12-09
Description : The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike. The webinar will explore the principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation. The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis. Areas Covered in the Session : Why Risk / Hazard Analysis is important Risk Assessment Defined Regulatory Requirements Risk Management Process – The Risk Management Plan Risk Management Documentation Risk Analysis Processes and Techniques Asking the Right Questions The Evaluation / Analysis Tools – FTA, FMEA, and FMECA Risk Control / Mitigation Who Will Benefit: Research & Development Quality Professionals Compliance Staff and Officers Regulatory Affairs Engineering Device Design Team Device Development Team Consultants
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