Risk Management Workshop for Medical Device …...RISK MANAGEMENT WORKSHOP UL’s comprehensive Risk...
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RISK MANAGEMENT WORKSHOP UL’s comprehensive Risk Management Workshop is presented by Mark Leimbeck of UL’s Advisory Solutions team and focuses on Risk Management and ISO 14971. This learning solution includes a self-paced eLearning course and a two- day hands-on workshop, covering basic risk management product lifecycle. This Workshop includes case study exercises throughout, providing participants first-hand experience implementing Risk Management concepts to facilitate application in their own situations. The Workshop also covers the Content Deviations of the EN ISO 14971: 2012 version of the standard, exploring strategies and examples to demonstrate what is needed for regulatory compliance. Other implementation considerations covered include: • Best practices to help organizations streamline their implementations; • Common misconceptions that frequently hinder implementation of Risk Management principles in an organization; • Where and how Risk Management directly supports and enables compliance with regulatory requirements, such as: 21 CFR Part 820 of the Food and Drug Administration’s Quality System Regulation, and ISO 13485 (the foundation for many Regulatory programs throughout the world). Instruction is targeted to professionals involved in risk management and ensuring effective implementations. Given the broad application of risk management, this material is extremely valuable to professionals working across the entire product lifecycle, including: R&D, manufacturing, packaging, logistics, supplier quality, marketing, sales, product support and regulatory affairs. About the Presenter: Mark Leimbeck is an Advisory Solutions Consultant and Program Manager for UL Compliance to Performance. Through his career, Mark has served UL in Management, Technical and Program Development roles, and led development of Certification Programs and services covering; Risk Management, Product Safety, Supplier Controls, and Restriction of Hazardous Substances (RoHS); Mark is the Chair of UL’s Health Sciences Council; he is also currently serving on the following committees: • FDA CDRH/AAMI Risk Framework Initiative, Sub-Group 4 • ISO (International Organization for Standardization) ISO/TC210 – IEC/ SC62A/JWG1Application of Risk Management to Medical Devices • USTAG for IEC (International Electrotechnical Commission) TC 62 Electrical Equipment in Medical Practice • IECEE (CB Scheme) Risk Management Task Force Mark is a Registered Professional Engineer, a Registered RABQSA Auditor, and holds a B.S.E.E.T. from Southern Illinois University and an M.B.A. from the University of Chicago. Register for the Risk Management Workshop at ULComplianceToPerformance.com/Risk_Management-ISO14971_Workshop Multiple dates are available, or arrange a Private Workshop at your location. Advisory Solutions for Risk Management In addition to Risk Management support, UL’s Advisory Solutions provides expertise in deploying enterprise-wide learning, processes and documentation for regulated industries. This includes an array of services from LMS Optimization & Best Practices to Audit and Compliance Services. Our experts work along-side your team to build a quality and compliance program to meet regulatory requirements as well as your unique objectives. We focus on meeting customer-specific needs, resulting in an improvement of their quality processes and systems. Click here to learn more. Presented by UL Compliance to Performance’s Advisory Solutions
Transcript of Risk Management Workshop for Medical Device …...RISK MANAGEMENT WORKSHOP UL’s comprehensive Risk...
Risk Management Workshop for Medical Device Organizations
RISK MANAGEMENT WORKSHOP
UL’s comprehensive Risk Management Workshop is presented by Mark Leimbeck of UL’s Advisory Solutions team and focuses on Risk Management and ISO 14971. This learning solution includes a self-paced eLearning course and a two-day hands-on workshop, covering basic risk management product lifecycle.
This Workshop includes case study exercises throughout, providing participants first-hand experience implementing Risk Management concepts to facilitate application in their own situations.
The Workshop also covers the Content Deviations of the EN ISO 14971: 2012 version of the standard, exploring strategies and examples to demonstrate what is needed for regulatory compliance. Other implementation considerations covered include:
• Best practices to help organizations streamline their implementations;• Common misconceptions that frequently hinder implementation of Risk
Management principles in an organization;• Where and how Risk Management directly supports and enables compliance
with regulatory requirements, such as: 21 CFR Part 820 of the Food and Drug Administration’s Quality System
Regulation, and ISO 13485 (the foundation for many Regulatory programs throughout the world).
Instruction is targeted to professionals involved in risk management and ensuring effective implementations. Given the broad application of risk management, this material is extremely valuable to professionals working across the entire product lifecycle, including: R&D, manufacturing, packaging, logistics, supplier quality, marketing, sales, product support and regulatory affairs.
About the Presenter:
Mark Leimbeck is an Advisory Solutions Consultant and Program Manager for UL Compliance to Performance.
Through his career, Mark has served UL in Management, Technical and Program Development roles, and led development of Certification Programs and services covering; Risk Management, Product Safety, Supplier Controls, and Restriction of Hazardous Substances (RoHS);
Mark is the Chair of UL’s Health Sciences Council; he is also currently serving on the following committees:
• FDA CDRH/AAMI Risk Framework Initiative, Sub-Group 4
• ISO (International Organization for Standardization) ISO/TC210 – IEC/SC62A/JWG1Application of Risk Management to Medical Devices
• USTAG for IEC (International Electrotechnical Commission) TC 62 Electrical Equipment in Medical Practice
• IECEE (CB Scheme) Risk Management Task Force
Mark is a Registered Professional Engineer, a Registered RABQSA Auditor, and holds a B.S.E.E.T. from Southern Illinois University and an M.B.A. from the University of Chicago.
Register for the Risk Management Workshop at ULComplianceToPerformance.com/Risk_Management-ISO14971_Workshop
Multiple dates are available, or arrange a Private Workshop at your location.
Advisory Solutions for Risk ManagementIn addition to Risk Management support, UL’s Advisory Solutions provides expertise in deploying enterprise-wide learning, processes and documentation for regulated industries. This includes an array of services from LMS Optimization & Best Practices to Audit and Compliance Services. Our experts work along-side your team to build a quality and compliance program to meet regulatory requirements as well as your unique objectives. We focus on meeting customer-specific needs, resulting in an improvement of their quality processes and systems. Click here to learn more.
Presented by UL Compliance to Performance’s Advisory Solutions
Risk Management Workshop for Medical Device Organizations
T: 609.627.5300 | W: ULComplianceToPerformance.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540 Page 2
Course Details:UL’s ISO 14971: Risk Management for Medical Device Organizations course is available to workshop registrants as a self-paced, 40 minute eLearning activity intended to be a precursor to the workshop. The course is also available to subscribers of our Medical Device GMP Course Library.
Engineers, product designers, senior executives and other integral personnel will gain a detailed overview of the application of Risk Management activities for medical device product safety through implementation of ISO 14971, including:
• Key terms associated with addressing risk, such as “Hazardous Situation,” “Failure Mode.”
• Development and implementation of a Risk Management Plan which is required to establish a policy on how the acceptability of risks will be determined.
• ISO 14971 emphasizes that commitment of top management is critical for an effective Risk Management process.
• Conducting a Risk Assessment, Risk Analysis and Risk Evaluation, and examine helpful tools such as Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), and Failure Mode Effects and Criticality Analysis (FMECA).
• Use risk control measures, potentially reducing the severity of, or the probability of occurrence of harm, or both.
eLearning Course:ISO 14971: Risk Management for Medical Devices (DEV55)
About UL Compliance to Performance
UL Compliance to Performance provides knowledge and expertise that empowers Life Sciences organizations globally to accelerate growth and move from compliance to performance. Our solutions help companies enter new markets, manage compliance, optimize quality and elevate performance by supporting processes at every stage of a company’s evolution. UL provides a powerful combination of advisory solutions with a strong modular SaaS backbone that features ComplianceWire®, our award-winning learning and performance platform.
UL is a premier global independent safety science company that has championed progress for 120 years. It’s more than 12,000 professionals are guided by the UL mission to promote safe working and living environments for all people.
To learn more about the ISO 14971: Risk Management for Medical Device Organizations course, or other regulatory compliance solutions, contact Pat Thunell at [email protected].
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