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 Overview | |
| Management Responsibilities | |
| Risk Management at CDRH | |
| Design Input | |
| DAY
2 8:00 AM- 5:00 PM |
Design Input (cont) Design Output Software Risk Management/td> |
| DAY
3 8:00 AM-12:00 PM |
Design Transfer |
| OverallResidual Risk | |
| 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/(R) 2010 - 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.
Dates and Hotels
| DATE | LOCATION | PHONE & RATES |
| October 30 - November 1, 2013  |
Red Rock Casino Resort Spa 11011 West Charleston Boulevard Las Vegas, NV 89135 Website |
866-767-7773 | 702-797-7777 $140 single/double Rate through 10/6/2013 |
| NOTE: Reservation requests should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. | ||
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
Fee includes PowerPoint presentations and case studies; relevant standards and/or technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional members | $1835 |
| AAMI individual members | $1935 |
| Nonmembers | $2235 |
| Government employees | $635 |