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

May 4-7, 2015

Online Registration

Hotel Monaco Alexandria
480 King Street
Alexandria, VA 22314
Website
+1-703-549-6080
Single/double rate: $239
Rate through: April 27, 2015
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

REGISTERFee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments.

REGISTRATION TYPE

2015 FEES

AAMI members
$2435
Nonmembers
$2735
Government employees
$835


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