Courses

Industrial Sterilization for Medical Devices

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.

Course Objectives:

Course participants will learn how to:

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.

Program At-A-Glance

DAY ONE
8:00 am–5:00 pm

Introduction
Key Concepts / Definitions
Microbes and Sterilization
Test Method Validation
Inactivation of Microorganisms

DAY TWO
8:00 am–5:00 pm

Sterile Packaging
Radiation Sterilization — Introduction
Radiation Sterilization — Process Definition and Dose Establishment
Radiation Exercise 1
Radiation Exercise 2
Radiation Sterilization—Product Definition & Routine Processing

DAY THREE
8:00 am–5:00 pm

Moist Heat and Ethylene Oxide Product Definition
Moist Heat Sterilization — Introduction
Moist Heat Sterilization — Process Definition
Moist Heat Sterilization — Routine Processing
Ethylene Oxide Sterilization — Introduction

DAY FOUR
8:00 am–5:00 pm

Ethylene Oxide Sterilization — Process Definition
Ethylene Oxide Sterilization — Routine Processing
Contract Sterilizers& Laboratories
FDA Perspectives


Course 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.

Who Should Attend?

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.

Dates and Hotels

DATES LOCATION PHONE & RATES
April 29 – May 2, 2014
The Westin Arlington Gateway
801 N. Glebe Road
Arlington, VA 22203
Website

1-888-627-7076
Single/double rate: $215
Rate through April 5, 2014

NOTE: 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-served basis and may sell out prior to the deadline.

Faculty

In consultation with industry and government leaders, this course was developed to meet the medical device industry's need for a better understanding of sterilization principles, standards, and regulations. The mix of industry leaders, independent experts, and FDA personnel helps to ensure a balanced presentation of many aspects of industrial sterilization as described in the objectives.

Fee and Registration

Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.

REGISTRATION TYPE
2014 FEES
AAMI corporate and institutional members
$2235
AAMI individual members
$2335
Nonmembers
$2735
Government employees
$835


RETURN TO TOP