The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements- December 2019

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements- December 2019 is organized by Association for the Advancement of Medical Instrumentation (AAMI) and will be held from Dec 09 - 13, 2019 at AAMI Center for Excellence (ACE), Arlington, Virginia, United States of America.

Target Audience:
Instruction is targeted to professionals directly involved in meeting both FDA and international quality system requirements or those who are ultimately responsible for the 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.

Description:
This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices­­-Application of Risk Management to Medical Devices.

This is an updated version of our previous Quality System Requirements and Industry Practice course. Included are important developments in world-wide medical device regulations and revised standards, specifically 13485 and the International Medical Device Regulators Forum Medical Device Single Audit Program (MDSAP).

Program Objective:
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 an 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 the learning industry best practices in implementing a QMS that meets global requirements.