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Event Registration - The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements

Start Date:
Monday, April 16, 2018
End Date:
Friday, April 20, 2018
Description: The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, industry consultants and members of ISO standard development teams for standards such as 13485 and ANSI/AAMI/ISO 14971:2007(R)2016, Medical devices Application of Risk Management to Medical Devices.
  • Event Location
    • Address:
      Westin Arlington Gateway
      801 North Glebe Road
      Arlington, VA 22203
  • Hotel Info

    • Course Location: Westin Arlington Gateway
      801 North Glebe Road 
      Arlington, VA 22203
      Phone: 703-717-6200

      For further information about the hotel, transportation, and local attractions, please visit the Westin's website Here.

      Sleeping room rates are available at $243 for a single or double room per night. The room rate is good through March 25, 2018.  Hotel Reservation Link

      NOTE: Hotel room space limited, 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-serve basis and may sell out prior to the deadline. AAMI cannot guarantee room block rate.

  • 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.)

      Dietary Restrictions . . .If you have any dietary restrictions, please notify AAMI staff prior to arriving on-site at the course. AAMI will use our best efforts to work with the vendors and caterers to accommodate your dietary needs. However, we cannot guarantee that all food served during the course will meet your dietary needs and restrictions. Should you have any dietary restrictions, you must sign a waiver form where you acknowledge that, if you have food allergies or other specified nutrition concerns, it is your sole responsibility to make the final judgment on whether or not to question the ingredients of a food item or to eat the foods selected. AAMI disclaims all liability for accidental or intentional ingestion of any food that does not meet your dietary restrictions or needs.

      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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