Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.
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Effective and compliant computer system validation is critical to any FDA-regulated organization, including those manufacturing, testing and distributing tobacco products. During the past 30 years, best practices have been developed for other FDA-regulated industries to ensure that the cost of building and managing a computer system validation program for this purpose, along with the necessary policies and procedures.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link http://onlinecompliancepanel.com/webinar/LEGAL-REGULATORY-POLICY-VALIDATION-FDA-501540/SEPTEMBER-2016-ES-TRAININGREGISTRY