Skip to main content

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

Upcoming Virtual Courses

Quality Systems

Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Nov24)

Nov 18 to Nov 22, 2024

Register

Quality Systems

Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (April25)

Apr 14 to Apr 18, 2025

Register

Quality Systems

Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Aug25)

Aug 18 to Aug 22, 2025

Register

Overview

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.

Objectives

Upon completing this program, participants will take home the knowledge to examine their quality management system to determine if it complies with both FDA Quality System requirements and 13485 requirements and recognize where improvements are needed. Participants will learn about the FDA inspectional approach and the Medical Device Single Audit Program. This course will empower the attendee with the knowledge to successfully host a FDA/MDSAP audit.

 

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 global requirements.

Who Should Attend?

Instruction is targeted to professionals directly involved in meeting both FDA and international quality system requirements or those who are ultimately responsible for compliance, including harmonization with 13485. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of a quality management system.

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of ANSI/AAMI/ISO 13485:2016, the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.

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 education@aami.org.

Faculty

Margaret Koga Ward

Margaret Koga Ward has over 30 years of medical device experience, specializing in Product Development, Quality Management Systems, Internal and External Auditing, and Risk Management.  She is currently an Independent Consultant, a Notified Body Auditor specializing in MDSAP and ISO 13485 audits, and an AAMI University faculty member.  Her passion is helping companies achieve their quality management system and product development goals to advance their devices from concept through to commercialization within an FDA and ISO compliant quality system. 

Ms. Koga Ward has served as a consultant for the FDA to develop and present quality management training courses for multiple divisions within the FDA. 

Prior to becoming an independent consultant, she held various senior level project management, quality management system, and engineering positions leading cross functional teams throughout all phases of product development and quality system integration.  

Ms. Koga Ward served as the Project Manager responsible for the integration, development, and commercialization of a novel, invasive device.  She was also the senior consulting engineer for an Arizona based consulting firm; in this role she managed quality and product development projects for a wide range of Class I, II, and III medical devices including orthopedic, cosmetic, cardiac, ocular, and gastro-esophageal devices.  She is an established subject matter expert for FDA regulations, ISO 13485, risk management, packaging, human factors, biocompatibility, and sterilization. 

Ms. Koga Ward holds a Mechanical Engineering degree from California Polytechnic University San Luis Obispo. 

Philippe Joly

Philippe Joly is the founder of e@syGMP, a training and consulting firm. He works mainly with European-based 

client firms to establish cGMP/QSR-compliant quality systems or to improve the efficiency of the existing ones. He has 10 years of experience in developing and delivering training on cGMP/QSR. Prior to this job, Philippe Joly has been involved in sales, marketing and product development for two international companies involved in the biopharmaceutical and medical device market. 

Philippe Joly has a MS degree in Biochemistry and Microbiology and a Master's in Management and Marketing. He has led several workshops and task forces (Personnel qualification, cleaning validation, validation of computerized systems, risk management) for the two main French Pharmaceutical societies.