Since 1996 with the publishing of both the US FDA 21 CFR 820 Quality System regulation and ISO 13485:1996, the requirements for Corrective and Preventive Action (CAPA) came into being for the medical device industry. Over time, the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action. Additionally over the years, global regulatory auditors have “unofficially” enforced erroneous concepts like - every audit finding internal or external requires a CAPA, every nonconformance requires a CAPA, or every complaint trend requires a CAPA. The Medical Device/IVD industry has fallen into some poor and unsustainable practices related to the foundational requirements established back in 1996.
In this session, learn how manufacturers are required to establish processes and define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities. Discuss good practices on how manufacturers are establishing processes for when and how to deal with containments, corrections, corrective actions, systemic corrective actions, OR preventive actions. Reassess current practices on how escalation and improvement actions are addressed commensurate with the significance or risk of the nonconformity or potential nonconformity.
With the FDA incorporating ISO 13485:2016 by reference into the Quality Management System Regulation with additional country-specific requirements, effective February 2026 – now is a perfect time to level set good practices to meet the intent of the Improvement Process in ISO 13485:2016 Clause 8.
Join Kim, in person, as she discusses with you how to:
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Recognize historical elements as to how and why the industry has fallen into some skewed practices so that we can learn from the past and adjust properly for future implementation by the FDA and other global regulators.
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Understand the depth of the requirements and the obligation of setting up proper systems across many aspects of your organization in order to meet the intent of the regulatory requirements.
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Ensure proper linkages and foundations within the QMS and RMS systems to ensure successful implementation and defensibility during regulatory audits.
Who should attend? Any quality-minded individual who wants to understand how to establish processes and define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities.
Venue ONSITE: St. Cloud State - Plymouth Campus, 9750 Rockford Rd, Suite #100, Plymouth MN
Date: Tuesday, April 15, 2025
Time: 5:30 pm to 8:30 pm CST
Cost: ASQ Members $80
Non-Members $125
Students, $15 or free when registering with your valid current school email and code BMCS
Groups of 5 or more $80
Certificates of Completion: Issued via email, after event completion, for .3 ASQ RUs or .3 CEUs
Questions: Please contact Karen Peifer, Committee Chair at asqmnbmc@gmail.com
SPACE IS LIMITED SO REGISTER SOON.
Select the 'MORE INFORMATION' link below to register.
Your Speaker
KIM TRAUTMAN, M.S., Medical Device, IVD and Combination Product Expert
Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 40 years of experience. She worked at the US Food and Drug Administration (FDA) for over 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators, and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.
Expert in global medical device regulations, wrote and harmonized the 1996 US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert.
EDUCATION
M.S. of Biomedical & Medical Engineering, University of Virginia, Charlottesville, VA
B.Sc. of Molecular Cell Biology and Engineering Sciences, Pennsylvania State University, State College, PA