Courses

Design Control Requirements and Industry Practice

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 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

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

March 4-6, 2015

Online Registration

Westin Crystal City
1800 Jefferson Davis Hwy
Arlington, VA 22202
Website
+1-703-486-1111
Single/double rate: $239
Rate through: February 16, 2015

June 15-17, 2015

Online Registration

Hilton New Orleans
333 St. Charles Avenue
New Orleans, LA 70130
Website
+1-504-378-2800
Single/double rate: $139
Rate through: May 25, 2015

October 21-23, 2015

Online Registration

Hotel Monaco Alexandria
480 King Street
Alexandria, VA 22314
Website
+1-703-549-6080
Single/double rate: $199
Rate through: October 5, 2015

December 2-4, 2015

Online Registration

Sheraton Fisherman's Wharf Hotel
2500 Mason Street
San Francisco, CA 94133
Website
+1-415-362-5500
Single/double rate: $169
Rate through: November 17, 2015
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.

REGISTRATION TYPE

2015 FEES

AAMI members
$2035
Nonmembers

$2335

Government employees
$735

 

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