APPLYING ISO1 AND IEC4 2017 - Seminar on Applying ISO14971 and IEC62304 - A guide to practical Risk Management
Website http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900750SEMINAR?channel=mailer |
Category "Risk management,ISO14971,medical device,Regulatory Compliance Training,Compliance Training Online,seminar on Applying ISO14971,FDA Compliance Training,Compliance Seminars"
Deadline: March 07, 2017 | Date: March 09, 2017-March 10, 2017
Venue/Country: San Diego, U.S.A
Updated: 2017-01-04 17:42:28 (GMT+9)
Call For Papers - CFPOverview: Gaps, incorrect or incomplete implementation of safety functionality 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 devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.Who Will Benefit:The course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner's perspective.Following personnel will benefit from the course:• Senior quality managers• Quality professionals• Regulatory professionals• Compliance professionals• Project managers• Design engineers• Software engineers• Process owners• Quality engineers• Quality auditors• Medical affairs• Legal ProfessionalsAgenda:Day 1 Schedule:Lecture 1: Introduction into Risk Management and Quality System Integration• Why risk management?o Historical perspectiveo International regulatory / statutory requirements• Risk Management Lifecycle and stakeholderso Over-reaching concepto Integration into ISO13485o Lifecycle steps• Risk Management Benefitso Liability issueso Streamlining product developmento Improving product safety and quality• How to Implement Risk Management into ISO13485o SOP frameworko Planning and executiono Monitoring and controlLecture 2: Risk Management to ISO 14971:2012o Risk Management Planningo Risk Management Life Cycleo Hazard Identification Hazard Domains Hazard Latency Issues Risk Rating Methodso Initial (unmitigated) Risk Assessmento Mitigation Strategies and Prioritieso Mitigation Architectures Alarm Systems as Mitigations Risk Control Bundleso Post Mitigation Risko Residual Risk Safety Integrity Levelso European special requirements (Z-Annexes)o Safety Requirementso Hazard Mitigation Traceabilityo Verification Planningo Architectures, Redundancy and Diversityo Failure Mode and Effect Analysiso Tips and Trickso Q&ADay 2 Schedule:Lecture 1: Usability and Risk Management• Use errors as hazard source• User intervention as hazard mitigation• Usability engineering lifecycle• Application specification• Usability Specification• Frequently used functions / primary operating functions• Usability verification / validation• Upcoming changes IEC62366:2014Lecture 2: Software Risk Management (IEC62304 / FDA software reviewers' guidance):• Critical Software Issues• Software Hazard Mitigation Strategies• Software Item, Unit and System Definition• Software Failures as Hazard Sources• Software Requirements and Design Specification• Software Tools and Development EnvironmentLecture 3: Software Risk Management (IEC62304 / FDA software reviewers' guidance):• Software Unit and Integration Testing• Real-Time System Challenges• Software Verification and Validation• Mitigation Traceability and Effectiveness• Software Maintenance and Configuration Control• Software Risk Management Process integration into ISO14971• Legacy Software issues• FDA documentation requirements• Upcoming changes in IEC62304:2014• Tips and TricksLecture 4: Safety / Assurance case• Safety classeso Basic Safety / Environmento Essential performance• Documentation of Basic Safetyo Electrical Safetyo Mechanical Safetyo EMC / RFI safetyo Safety margins• Documentation of essential performanceo What is essential performance?o Device architectures and mitigation allocationo Device specific mitigationso Software mitigations• External safetyo User intervention and alarmso Organizational measureso Levels of protection concept• Verification of safety propertieso Type testingo Sample testingo Software verification testingo Inspectionso Analyses• Assurance case vs. Risk Management Reporto General safety and hazard avoidanceo Device / application specific issues• Tips and Tricks• Q&ASpeaker:Markus WeberPrincipal Consultant, System Safety Inc. Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.Location: San Diego, CA Date: March 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PMVenue: Four Points by Sheraton San Diego DowntownAddress: 1617 1st Avenue - San Diego, California, 92101 - United StatesPrice:Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until January 31, Early Bird Price: $1,295.00 from February 01 to March 07, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: firstname.lastname@example.org
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