Dates: November 17–19, 2020 from 8:00 a.m. to 5:00 p.m. ET
This comprehensive three-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the lifecycle of the product (design, manufacturing, post-production, retirement). Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards during risk management activities.
Join us to...
- Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements.
- Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email firstname.lastname@example.org.
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Tina Krenc, Tonya Wilbon
Principal Consultant, KTA Compliance Consulting
Tina is a compliance consultant for her own company, after over 34 years working in several different divisions of Abbott. She started at Abbott in Research and Development working on In-vitro diagnostic products. Her medical device experience includes IVD’s, software, hardware, combination products, and implantable medical devices. In her 34+ years at Abbott, Tina has had experience in research and development, clinical research, operations technical support, and over 25 years of Quality Assurance experience in multiple quality organizations. She was the project coordinator for developing and implementing a worldwide design control quality system and risk management process for Abbott Diagnostics Division and refreshing the risk management and design control processes in two other Abbott medical device divisions.Tina serves as member of ISO/TC 210 Joint working group on Application of Risk Management to Medical Devices. In addition, she was a Risk Management Subject Matter Expert for ISO/TC212 the In-vitro Diagnostics Technical Committee. She has presented risk management at International meetings, as well as at CLMA, AAMI/FDA, and for ADVAMED. Most recently, Tina joined one of the committees responsible for the AAMI/FDA publication on Post-market Risk Management. She also presented, and was a panelist at a summit of the same title in September of 2015. Tina received her Masters of Science in Product Design and Development from Northwestern University School of Engineering in 2006. Tina teaches Risk Management for the Association for the Advancement of Medical Instrumentation (AAMI) and developed, and developed and taught a risk management and decision making course for Northwestern’s Master of QARA program.
Biologist, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, U.S. Food and Drug Administration
Tonya A. Wilbon is a Biologist for the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health (OIR). She currently serves as a Quality System Specialist and a Compliance Reviewer and previously served as a Scientific Reviewer within OIVD. Ms. Wilbon has been with the agency for over 13 years with more than 10 years of clinical laboratory experience. She serves as an FDA Instructor for several courses for the Association for the Advancement of Medical Instrumentation (AAMI) including the Quality System Regulation Requirements and Industry Practice course, Integrating Risk Management into Quality System course and the Design Controls course. She has assisted with writing several inter-office procedural documents such as the Quality System Regulation requirements review procedure, premarket establishment inspection review procedure and manufacturing site change supplements procedure and has assisted with revising the FDA guidance document entitled, “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions”. Ms. Wilbon has assisted with drafting a guidance document entitled, “Draft Guidance Document for Clinical Laboratories, Industry and FDA Staff: Quality System Requirements Guide for Laboratory Developed Tests” while serving as an FDA Commissioner’s Preceptor. She currently serves as a member of the Area Committee for Quality System and Laboratory Practice and a member of the Subcommittee on Antimicrobial Susceptibility testing of Human Mycoplasmas for the Clinical and Laboratory Standards Institute (CLSI).Ms. Wilbon graduated with a Bachelor of Science degree from Howard University and is a certified Microbiologist by the American Society of Clinical Pathologist (ASCP). She has completed several courses at the Johns Hopkins Graduate School of Public Health and the Howard University Graduate School of Arts and Sciences. Prior to her employment with FDA, she held positions in specialized areas of Kimbrough Army Community Hospital, Howard University Hospital and the Johns Hopkins Hospital in Baltimore, Maryland.