Design Control Requirements and Industry Practice
This intensive 2½ day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. The program has been revised to include more hands-on exercises, more "how-to" information on implementation of design control requirements, increased focus on life cycle aspects of risk management and human factors, and more up-to-date industry examples.
Objective
Upon completing this course, participants will be able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet both regulatory and business requirements.
Format
Program At-A-Glance |
|
| DAY
ONE 8:00 AM-5:00 PM |
Introduction to Design Control Scope and Applicability Design and Development Planning Design Input Risk Management Design Output |
| DAY
TWO 8:00 AM-5:00 PM |
Design
Review Design Verification Design Validation Design Transfer Software Validation |
| DAY
THREE 8:00 AM-NOON |
Design
Changes Design History File FDA Inspectional Approach |
This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Examples of design control tools, templates, and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program. During this highly interactive learning experience, participants are given ample opportunity to discuss the different approaches that can be taken depending on company size or device classification.
Who Should Attend?
Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.
Dates & Hotels
| DATE | LOCATION | PHONE & RATES |
| September 23-25, 2013 |
The Westin Alexandria 400 Courthouse Square Alexandria, VA 22314 Website |
866-837-4210 $209 single/double Reservation ID: AAMI Rate through: 8/16/2013 |
November 4-6, 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 request 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
Course faculty are drawn from an experienced group of quality system professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders and consultants helps to ensure a balanced presentation of the design control requirements and paths to compliance.
Fee and Registration
Fee includes PowerPoint presentations 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.
| REGISTRATION TYPE | FEES |
| AAMI corporate & institutional members | $1735 |
| AAMI individual members | $1835 |
| Nonmembers | $2135 |
| Government employees | $635 |