Risk Management and Analysis in a Regulated Environment: Process to Prevent, Mitigate, Control, and Reduce Your Risk
When AAMI presented this webinar event, it drew 850 members of the medical device community. If you missed the broadcast but would find the materials presented informative and useful, you're in luck. A CD of the program, accompanied by participant handouts, is now available for purchase. The webinar CD will give you an opportunity to hear directly from industry and the FDA as well as listen to questions and answers from the live broadcast.
FORMAT
The two-hour program was conducted by a representative from industry
and a risk management expert from the U.S. Food and Drug Administration.
Their presentations were supplemented by an interactive case study
and handout that showed how to think critically through risk analysis
situations. Three question and answer sessions were held during
the course of the program.
TARGET AUDIENCE
Instruction
was targeted towards quality assurance and regulatory affairs personnel,
design and process engineers, manufacturing and operations managers,
and members of research and development or new product development
teams. To receive the maximum benefit from the
webinar, it is recommended that individuals have a thorough understanding
of ISO 14971, and are actively implementing the standard into their
quality system.
PROGRAM-AT-A-GLANCE
- Understand FDA’s perspective on risk management
- Comply with FDA’s safety and risk management requirements
- Recognize the origin of risk and its sources
- Identify types of risk and how to address them from a top-down and bottom-up strategy
- Apply the critical thought process presented during webinar to analyze risk to products, processes, and design in a pre and post environment
- Control risk using preventive and mitigation strategies
- Document
and record risk control using risk analysis reports
SPEAKERS
- Ken Peterson, President, PathWise, Inc.
- Erin Keith, Materials Engineer, Office of Compliance, Center for Devices and Radiological Health, U.S. Food and Drug Administration
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 301-206-9789.
- Mail - Select and download the order form and mail with payment to:
Risk Management 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. For CD content questions, please contact Virginia Schoenauer
at 703-525-4890, ext. 247.