Sterility Assurance Levels for Medical Products Based on ANSI/AAMI ST67:2003 Requirements for Products Labeled 'STERILE'
Determining appropriate sterility assurance levels (SALs) or maximum contamination rates are critical steps in producing medical products that are safe, effective, and free from hazardous microorganisms. Based on the American National Standard, ANSI/AAMI ST67:2003 Requirements for Products Labeled "STERILE," this webinar addressed the decision-making steps that you and your company should go through before validating a sterilization or aseptic manufacturing process.
This webinar CD is essential to those who are responsible for:
- Identifying sterility assurance levels for medical products dependent on the products' intended use.
- Defining validation goals for terminal sterilization and/or aseptic processing.
- Sterilizing medical devices or combination products.
- Complying with international quality system regulations or industrial
sterilization standards.
PROGRAM-AT-A-GLANCE
- Provides an overview of SALs and instruction on the meaning of D-Values.
- Helps you determine an appropriate SAL or maximum contamination rate for medical devices to be labeled "sterile" and answer your questions on why you would choose one SAL over another.
- Discusses the difficulties manufacturers encounter in obtaining a desired SAL for a sterilization process and mechanisms for overcoming these difficulties.
- Compares European Norms with the US standard and what you need to know to comply with both.
- Discusses the issues surrounding the differences between terminal
sterilization and aseptic processing.
SPEAKERS
- Joyce Hansen, President, J.M. Hansen & Associates, Inc.
- Cathy Nutter, Microbiologist, US Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation
- Eamonn V. Hoxey, Ph.D., BPharm, Executive Director for Quality & Compliance Worldwide, Johnson & Johnson
WEBINAR CD
- Includes handout material and CD
- $245 for webinar registrants / $345 for non-registrants
- Please note that domestic and international shipping rates apply
THREE WAYS TO ORDER
- Phone - 1-877-249-8226 / 240-646-7031, to order with credit card
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
ST67 Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI Publications at 1-877-249-8226 / 240-646-7031.