SAVE THE DATE:

Failure Analysis, Product Recalls, and Liability:
Preventative Measures to Help Prevent the FDA
From Knocking on Your Door

Join us for an interactive discussion on medical device/biotech design analysis, regulatory compliance, and liability issues.

The current regulatory and litigation environments in the United States require that potential safety issues and problems with mass-produced products be vigorously investigated and quickly remedied.

How well a company manages a recall situation or deals with compliance problems (identified, for example, in a FDA Form 483 or Warning Letter) can affect not only the future viability of the product and the company’s liability and financial status, but the company’s reputation and "brand equity."

A company’s success in responding to FDA concerns and communicating with the agency, customers, and health-care professionals, can significantly impact public perceptions and potential liability.  In addition, determining whether a device failure has occurred, and identifying and correcting its cause, are critical to avoiding government-imposed shut-downs, getting a product back on the market after a recall, and helping to avoid litigation.

We invite you to join Exponent, a leading consulting firm providing design, failure analysis, and recall support to biotech companies, and Crowell & Moring, LLP, a trusted and respected international law firm with deep and broad expertise in FDA compliance and products liability counseling and litigation defense, for an interactive discussion on these medical device/biotech design analysis, regulatory compliance, and liability issues.

Seminar topics will include:

• How to Use the FDA Regulated Design Process to Manage Risk: Elements of Design Controls and Why It Matters
• Materials Compatibility and Devices – Considerations and Consequences
• Human Factors in Healthcare

WHEN

January 29, 2013
Menlo Park
4:00 – 6:00 pm
Refreshments will be served

Exponent
149 Commonwealth Drive
Menlo Park, CA 94025
www.exponent.com

REGISTRATION

Please register by January 25

PRESENTERS

John H. Fuson, Esq.
Partner, Crowell & Moring, LLP

Kevin C. Mayer, Esq.,
Partner, Crowell & Moring, LLP

Jorge A. Ochoa, Ph.D., P.E.
Principal Engineer, Exponent

Maureen T. F. Reitman, Sc.D.
Practice Director, Exponent

Christine T. Wood, Ph.D.,
Practice Director, Exponent

Robert Rauschenberger, Ph.D.
Managing Scientist, Exponent

Click here for speaker bios