 |

Industrial Sterilization
for Medical Devices is a comprehensive
4-day course covering essential information on sterilization processing
in a medical device manufacturing environment. Developed by medical
device manufacturers, the U.S. Food and Drug Administration (FDA),
and industry consultants, the course addresses 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:
-
Apply the principles of sterilization
- Address
sterilization requirements during product design
- Select
and implement an appropriate sterilization process
- Identify
the elements of successful sterilization validation
- Describe
the critical parameters of a chosen sterilization process
- Participate
in the design of process validation for moist heat, ethylene oxide
(EO), and radiation sterilization processes
- Compare
and contrast sterilization cycle developments based on product
bioburden and those based on combined bioburden/overkill methods
- Correlate
appropriate standards with sterilization processes and identify
requirements pertinent to validation, packaging, and routine process control
- Describe
the critical factors in making product release decisions
- Identify
resources for complying with 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.
Program
At-A-Glance
DAY
ONE
8:00
AM-5:00 PM |
— Microbes and Sterilization
— Validation
— Test Method Validation
— Microbial Lethality (D-Values and SALs) |
DAY
TWO
8:00
AM-5:00 PM |
— Product Definition — Moist
Heat and Ethylene Oxide
— Sterile Packaging
— Moist
Heat Sterilization — Introduction
— Moist Heat Sterilization Validation — Process Definition |
DAY
THREE
8:00
AM-5:00 PM |
— Moist Heat Sterilization Validation — Routine Processing
— Ethylene Oxide Sterilization — Introduction
— Ethylene Oxide Sterilization Validation — Process Definition
— Ethylene Oxide Sterilization — Routine Processing |
DAY
FOUR
8:00
AM-5:00 PM |
— Radiation Sterilization — Introduction
— Radiation Sterilization — Dose Establishment, Product, and Process Definition
— Radiation Sterilization — Equipment Characterization, Validation, and Routine Processing
— FDA
Perspectives
— Contract Labs and Sterilizers |
|
Course
Materials
Participants will receive the following:
- ANSI/AAMI/ISO 17665-1:2006 Sterilization of health products – Moist heat – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical device;
- ANSI/AAMI/ISO 11137-1:2006 Sterilization of health products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
- ANSI/AAMI/ISO 11137-2:2006 Sterilization of health products – Radiation – Part 2: Establishing the sterilization dose;
- ANSI/AAMI/ISO 11137-3:2006 Sterilization of health products – Radiation – Part 3: Guidance on dosimetric aspects;
- ANSI/AAMI/ISO 11135-1:2007 -- Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
- ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging, 3ed
- ANSI/AAMI/ISO 11607-2:2006 11607-2 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes
- AAMI TIR22:2007 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006
- Pertinent FDA documents; additional references; and a participant's guide for easy note-taking.
Who
Should Attend?
To maximize the peer-learning opportunity,
this course is recommended for those who are relatively new to the
sterilization process environment and need information to help them
better understand the principles and science of industrial sterilization.
This course is designed for professionals such as 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 |
| October 13-16, 2008 |
The Westin Arlington Gateway *
801 North Glebe Road
Arlington, VA 22203
Web site |
888-627-7076
/ 703-717-6200
$199 single/double
rate through Sep 15, 2008 |
| 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. |
| * Due to the number of events that AAMI is holding at The Westin Arlington Gateway in 2008, it is necessary to specify which course you are attending when making your room reservation. |
|
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.
Registration
Fees
Fee includes course materials and continental breakfast, lunch, and refreshment
breaks for all four days.
| REGISTRATION
TYPE |
2008
FEES |
| AAMI
Corporate & Institutional Member |
$1885 |
| AAMI
Individual Member |
$1985 |
| Nonmember |
$2385 |
| Government
Employee |
$585 |
|
Join
AAMI and Save!!
Link
to Membership
| MEMBERSHIP
TYPE |
2008
FEES |
| U.S.
Individual Membership Rate |
$200 |
| Non-U.S.
Individual Membership Rate |
$260 |
|
RETURN TO TOP
|
|