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December 20, 2012 -- 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. Seminars to be held January 29th in Menlo Park, CA and January 31st in Los Angeles.
Seminar topics will include:
How to Use the FDA Regulated Design Process to Manage Risk: Elements of Design Controls and Why It Matters
Materials Compatability and Devices – Considerations and Consequences
Applying Human Factors in Design / Labeling / Instructions