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Event Registration - Purchasing Controls & Supply Chain Management-June 2019

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Start Date:
Wednesday, June 19, 2019
End Date:
Friday, June 21, 2019
Time:
8:00 AM - 12:00 PM Eastern Daylight Time
Description:

This 2½ day course provides extensive information on effective implementation of supplier selection and controls. This detailed course covers the key aspects of supplier controls, from planning for supplier assessment/selection, to defining acceptance activities, to monitoring supplier performance. Each topic is presented from a practical perspective, with links to the requirements of the Quality System regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.

The course also covers life-cycle management approaches for a medical device manufacturing organization’s supply chain. The course includes substantial “hands-on” exercises to allow attendees to apply concepts and interact with colleagues, and provides specific industry examples.

Registration Fees:

  • AAMI Members: $2135
  • Nonmembers: $2435
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM

Definitions and Regulatory Requirements

Planning

Supplier Selection



DAY 2 | 8 AM-5 PM

Supplier Selection Continued

Defining Supplier Controls

Day-to-Day Operations

Communications and Improvements



DAY 3 | 8 AM-12 PM

Integrating Supplier Controls Throughout the Quality Management Systems

Supply Chain Management

Submissions and Compliance






 

 

Program Objective

Upon completing this course participants will be able to evaluate their organization's compliance with FDA's requirements for purchasing controls and acceptance activities, and consider appropriate risk mitigation strategies for supplied products and services.

 

Target Audience

This course is targeted to professionals involved in establishing supplier agreements, supplier quality management, purchasing activities, Quality System compliance, and regulatory submissions for significantly outsourced products.

 

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. td>
  • Event Location
    • Address:
      AAMI Conference Center
      901 North Glebe Road Suite 300
      Arlington, VA 22203
      UNITED STATES
  • Hotel Info

    • Course Location: AAMI Conference Center
      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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