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Event Registration - Process Validation for Medical Devices: Requirements and Standards - October 2019

http://my.aami.org/aamiresources/images/events/901-Glebe.jpg
Start Date:
Tuesday, October 08, 2019
End Date:
Thursday, October 10, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time

This 3 -day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation, the ISO 13485:2016 Standard and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples.

Registration Fees:

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

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
Establishing Process Validation Procedures
Master Validation Planning
Installation Qualification
Characterization & Study Design


DAY 2 | 8 AM-5 PM 
Operational Qualification
Performance Qualification
Execution of Validation


DAY 3 | 8 AM-5 PM 
Monitoring & Control 
Revalidation
Advanced Planning & Validation Strategies 






 

Program Objective

FDA and AAMI faculty work together to help the learner to:

· Determine which processes require validation and develop a Validation Master Plan

· Develop protocol content to ensure a successful validation

· Document the results and the resolution of deviations that occur during validation execution

· Plan for effectively monitors and controls for their validated processes

· Determine the revalidation requirements for product and process changes

· Planning, Protocol Development, Validation Execution, Monitoring & Control and Revalidation to meet the FDA’s expectation and industry’s best practices

Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation post-course test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System Regulation and ISO 13485 Standard.

 

Target Audience

Instruction is geared to professionals involved with process validation in the medical device industry such as Manufacturing Leads, R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Manufacturing/Process Engineers. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of the Quality System regulation and have some relevant work experience.

 

Format

This 3-day program provides intensive coverage of process validation and includes a variety of real-life examples, case studies, and exercises that cover process validation activities. These exercises provide participants with the opportunity to apply new information to actual validation scenarios. The course includes a general description of statistical methods and tools as they relate to process validation.

 

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, a comprehensive eNotebook of all training materials and many of the referenced materials and case studies, pertinent FDA documents, and access to the online exam.


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

    • Course Location: AAMI Center for Excellence (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.

Registration is closed.