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Event Registration - Human Factors for Medical Devices - April 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg
Start Date:
Tuesday, April 30, 2019
End Date:
Thursday, May 02, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
This 3-day course offers participants a comprehensive overview to human factors as it relates to medical devices. It includes regulatory requirements of FDA, specifically the interpretation from the Center for Devices and Radiological Health (CDRH) Human Factors Team, as they relate to human factors, and the process of applying human factors in design controls during the design of a medical device. The course also includes the regulatory perspective of the Center for Drug Evaluation and Research (CDER) and the impact of human factors on pharma.

 

Registration Fees:

  • AAMI Members: $2235
  • Nonmembers: $2535
  • Government Employees: $950

 

Program Outline

 


DAY 1 | 8 AM-5 PM
  • Introduction and Overview 
  • Case Study 1
  • Preliminary Analysis: Uses, Users, Use Environments, and User Interfaces
  • Preliminary Analysis: Analytical Approaches to Identifying Use Related Risks
  • Preliminary Analysis: Use Related Risks Part 2, Task Analysis and PCA


DAY 2 | 8 AM-5 PM
  • Preliminary Analysis: Analytical Methods, Empirical Methods
  • Formative Exercises and Reporting
  • Root Cause Analysis 
  • Risk Elimination and Reduction Standards 
  • Rosetta Stone


DAY 3 | 8 AM-5 PM
  • FDA - CDRH and CDER
  • Validation Exercises
  • Group Presentations




 

 

Program Objective

A basic foundation for applying human factors will be set, with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.

 

Faculty

All course faculty have completed an instructor training program. On-going peer and participant evaluation ensure consistency and quality from course to course. The faculty team for each program includes a lead instructor and an industry expert(s).

 

Target Audience

This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have working knowledge of the Quality System regulation and design controls.

 

Format

A combination of situation analyses, case study exercises, and both formal and informal discussions are used throughout the program to provide maximum opportunity for the application of information.

 

 

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.

  • Event Location
    • Address:
      AAMI Center for Excellance (ACE)
      901 North Glebe Road Suite 300
      Arlington, VA 22203
      UNITED STATES
  • Hotel Info

    • Course Location: AAMI Center for Excellance (ACE)
      901 North Glebe Road Suite 300
      Arlington, VA 22203
      Phone: (703) 525-4890

      For further information about the hotels near AAMI, transportation, and local attractions, please visit the AAMI website at Hotel Reservation Information

  • Event Notes
    • Substitutions, Transfers, and Cancellations. . . In the event you are unable to attend this course, you may transfer your registration to a qualified colleague or apply your registration fee to a subsequent program, on a space-available basis. All substitution, transfer, and cancellation requests must be made in writing to AAMI Customer Service.

      Send a colleague to attend in your place . . . Substitutions can be made at any time prior to a program without penalty. No substitutions will be honored once a program begins.

      Transfer to a subsequent program . . . AAMI allows a one time transfer to a subsequent program as an alternative to cancellation. Transfer requests must be received by AAMI in writing (via e-mail or fax) no later than one week prior to the start of the originally registered program. (Please note: for those requests received within one week of the program, AAMI will assess a $400 transfer penalty in addition to the registration fee). Transfer requests must state alternate name and date of the program choice. Since programs are not all priced identically, the registrant is responsible for any increases in registration fees resulting from the transfer. No refunds for the difference between program prices will be made should the price of the program choice be less than the price of the originally registered program. Any request for a transfer beyond this one-time allowance will be treated as a cancellation (See Cancellation Policy).

      Cancellation . . . If AAMI receives a cancellation request at least one week prior to the program date, the registration fee minus a $400 cancellation fee will be refunded. No refunds will be granted for cancellations received by AAMI less than one week before the program.

      No Shows . . . Failure to attend a program for which you are registered will result in forfeiture of registration fees.

      AAMI Membership . . . Are you entitled to the member discount? Please call (800) 332-2264, ext. 1214, before you register and find out. If you are not a member, join AAMI for a special rate of $250 for an Individual Membership and $310 for an International Individual Membership to receive a discount on your registration fees.

      Course Confirmation . . . Confirmation notices will be distributed one week after your registration has been processed. You must have this confirmation to ensure course attendance.

      Contact Information . . . Your contact information will be provided on an attendee roster that will be distributed to course attendees and faculty. If you do not want your telephone number, fax number, and e-mail address provided to course attendees and faculty please email AAMI Customer Service. (This does not apply to AAMI's on-line membership directory.)

      Note . . . Please confirm course availability prior to submitting payment and making travel reservations. AAMI is not responsible for any airline or hotel cancellation fees if course availability is not confirmed prior to making travel reservations.



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