Registration Integrating Risk Management into the Quality System
This comprehensive course for medical device manufacturers presents risk management concepts used throughout the quality system as well as the lifecycle of the product, from design…to manufacturing…through post-production.
Course Objectives
Upon completion of the course, participants will have learned the basic terms of risk management, the appropriate tools for risk evaluation, FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system.
| Program At-A-Glance | |
| DAY 1 8:00 AM- 5:00 PM |
Risk Mgmnt. Throughout Product Life Cycle |
| Basic Terms and Concepts | |
| ANSI/AAMI/ISO 14971:2007 Overview | |
| Management Responsibilities | |
| Risk Management at CDRH | |
| DAY
2 8:00 AM- 5:00 PM |
Design Input Design Output |
| DAY
3 8:00 AM-12:00 PM |
Design Transfer |
| Overall Residual Risk | |
| Software Risk Management | |
| Production and Post-Production Information | |
Format
This 2½ day course provides intensive coverage of integrating
risk management practices and principles into a medical device manufacturer's
quality system. This highly interactive format includes relevant
examples from a broad product spectrum that demonstrate current
industry practices of risk management. In addition, interactive
exercises will allow participants to practice applying risk management
concepts, principles, and tools throughout the product lifecycle.
Course Materials
Participants
will receive a comprehensive notebook of all training materials.
Also distributed are the reference documents, ANSI/AAMI/ISO 14971:2007 - Medical devices - Application of risk management to medical devices, and GHTF Study Group 3's new guidance document, Implementation of Risk Management Principles and Activities within
a Quality Management System.
Who
Should Attend?
Instruction is targeted to quality assurance and regulatory
affairs personnel, design and process engineers, manufacturing and
operations managers, members of research and development or new
product development teams. For participants to gain the maximum
benefit from this course, it is recommended for those who have a
working knowledge of the Quality System regulation and design controls
or who have already attended AAMI's Quality System and Design Control
courses.
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Faculty
This course is taught by
a mix of independent experts, industry representatives experienced
in risk management, and FDA personnel. These instructors provide
a balanced presentation of many aspects of risk management principles
and practices as described in the objectives above.
Fees and Registration
Fees include participant notebook of course materials and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
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