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Event Registration - Industrial Sterilization for Medical Devices - May 2019

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Start Date:
Tuesday, May 14, 2019
End Date:
Friday, May 17, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time

Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Registration Fees:
  • AAMI Members: $2535
  • Nonmembers: $2835
  • Government Employees: $1050

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Introduction
Key Concepts/Definitions
Microbes & Sterilization
Test Method Validation
Inactivation of Microorganisms


DAY 2 | 8 AM-5 PM
Sterile Packagin
Radiation Sterilization - Introduction
Radiation Sterilization - Process
Definition and Dose Establishment
Radiation Exercises
Radiation Sterilization - Product
Definition and Routine Processing 



DAY 3 | 8 AM-5 PM
Moist Heat & Ethylene Oxide Product 
Moist Heat Sterilization
Ethylene Oxide Sterilization



DAY 4 | 8 AM-5 PM
Ethylene Oxide Sterilization
Contract Sterilizers & Laboratories
FDA Perspectives 






 

 

Program Objective

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

 

Target Audience

This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

 

Format

This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

 

 

Materials

As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.

  • 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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