Courses

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
8:00am -5:00pm
Introduction to Design Control
Scope and Applicability
Design and Development Planning
Design Input
Risk Management
Design Output
DAY TWO
8:00am-5:00pm
Design Review
Design Verification
Design Validation
Design Transfer 
Software Validation
DAY THREE
8:00am-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
June 11-13, 2014 The Brown Palace
321 17th Street
Denver, CO 80202
Website

1-303-297-3111
Single/double rate: $209
Rate through: May 19, 2014

October 15-17, 2014 The Westin Arlington Gateway
801 N. Glebe Road
Arlington, VA 22203
Website

1-888-627-7076
Single/double rate: $215
Rate through Sept. 23, 2014
Book your room online.

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
2014 FEES
AAMI corporate & institutional members
$1835
AAMI individual members
$1935
Nonmembers
$2235
Government employees
$635

 

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