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Event Registration - Corrective and Preventive Action Requirements and Industry Practice-June 2019

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Start Date:
Tuesday, June 18, 2019
End Date:
Wednesday, June 19, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Description: This 2 day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or validating actions; how to write good CAPA plans; how risk management is used in conjunction with the CAPA system; and 21 CFR and ISO 13485 requirements.

 

An optional exam is available online for 2 weeks following the end of the program.

Registration Fees:

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

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Regulatory Requirements
Planning for the CAPA System
Measurement and Analysis
Improvement - Investigations



DAY 2 | 8 AM-5 PM
Improvement - Investigations
Improvement - Implementation
Management Reporting
FDA Perspective and Compliance









 

 

Program Objective

Upon completion of this course, participants will be able to evaluate their organization’s compliance with FDA’s requirements for establishing a Corrective and Preventive Action system. Further, they will be able to implement a compliant business value-added CAPA system to effectively manage existing and potential product and quality system nonconformities.

 

Target Audience

Instruction is targeted to quality assurance, quality system compliance and regulatory affairs professionals; personnel responsible for the implementation of CAPA systems; and CAPA system management.

 

Format

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

 

 

Materials

Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents, additional references, and access to the online exam.

  • 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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