Event Overview
(Four 8-hour days 9:00am-6:00pm Irish Standard Time; One 4-hour day 9:00am-1:00pm Irish Standard Time)
Medical device manufacturers are required to implement and maintain a risk-based quality management system that complies with FDA’s amended 21 CFR 820, the Quality Management System Regulation (QMSR), which incorporates by reference ISO 13485:2016. The QMSR reflects a major shift in the FDAs’ expectations for an organization’s quality management system.
This engaging and immersive 4½-day course provides quality, regulatory, compliance, and operations professionals with a practical understanding of the QMSR. Participants will examine the structure, intent, and application of the updated regulation, with emphasis on how organizations can build, maintain, and continuously improve a compliant and effective quality management system.
Using the latest QMSR eNotebook as a foundation, the course focuses on current requirements, implementation considerations, inspection readiness, documentation expectations, and practical compliance strategies. Participants will also explore how the QMSR fits within the broader global regulatory environment, including international quality system expectations and programs such as the Medical Device Single Audit Program (MDSAP).
Instruction is built on decades of consensus and expertise from FDA officials, ISO standards developers, industry leaders, and quality consultants.
Program Objective
Upon completing this course, participants will be able to:
• Interpret the FDA QMSR final rule and its alignment with ISO 13485:2016.
• Evaluate their organization’s QMS against the FDAs requirements, identifying gaps and opportunities for improvement.
• Understand the FDAs’ expectations for risk management and risk-based decision making throughout the QMS.
• Prepare effectively for FDA inspections in addition to ISO 13485 and MDSAP audits.
In addition, this course covers best practices, recognizing that different approaches may apply to various medical device classifications and to company size. This course is the one stop resource for learning industry best practices in implementing a QMS that meets the FDA regulatory requirements.
Target Audience
This course is intended for professionals responsible for QMS compliance, including:
• Quality and regulatory affairs managers
• Design and production managers
• Internal auditors and consultants
• Anyone tasked with ensuring a risk-based approach to the QMS
AAMI recommends participants have a baseline understanding of quality management systems to maximize peer-to-peer learning.
Format
A combination of situation analyses, case-study exercises, review of sample recall and warning letters, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.
Materials
Fee includes a printed copy of the textbook, The Quality Management System Compendium, and electronic versions of ANSI/AAMI/ISO 13485:2016, 14971:2019, 24971:2020, the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.