Mismanaged product recalls can prove to be a drain on a business’ resources and reputation, both of which can erode a company’s bottom line for years to come. Timely, effective product recalls, on the other hand, can strengthen an organization’s brand image well into the future. Inefficient medical device reporting also presents a clear and present danger. It can damage your company’s reputation and even threaten your ability to operate. So how should an organization alter the way it does business to guarantee that if post-market problems arise, it is equipped to quickly meet and resolve these issues?
This audio conference, conducted by Caryn M. Silverman, partner at Sedgwick, Detert, Moran and Arnold LLP, provides practical, step-by-step information that will help guide you through these challenging post-marketing processes. She defines and discusses medical device reporting, recall classifications and strategies -- as well as where and when exceptions to the rule apply -- Dear Doctor letters and post-marketing surveillance.
This audio conference covers:
- How to evaluate complaints and determine whether they require further investigation
- Types of product recalls and strategies for implementation
- How to conduct ongoing monitoring of device performance
- Proper procedure for reporting corrections and removals
- What triggers safety alerts and physician communications (Dear Healthcare Provider letters)
- How to determine if a complaint is a Medical Device Report and what steps to take if it turns out to be a reportable event
About the speaker:
Caryn M. Silverman is a partner in the New York office of Sedgwick, Detert, Moran & Arnold LLP. An experienced trial and litigation attorney, Ms. Silverman handles product liability matters and has expertise in drug and medical device cases. In addition, she represents clients in healthcare, general commercial and toxic tort litigation, as well as pharmaceutical mass tort litigation, having represented clients as both national and local counsel. Ms. Silverman also provides risk assessment counseling, including regulatory compliance, and advises clients on the management, defense and prevention of litigation. She is a prolific author and frequent speaker on legal issues pertaining to FDA-regulated products for organizations such as the American Conference Institute, American Bar Association and various trade groups.
Ms. Silverman is vice chair of the New York State Bar Association's Food, Drug & Cosmetic Law Section. She is admitted to practice in New York and New Jersey, and before the U.S. District Courts for the Southern and Eastern Districts of New York and the District of New Jersey. She holds a B.S. from Cornell University and J.D. from Benjamin N. Cardozo School of Law, Yeshiva University.
Who should attend?
- Regulatory Affairs
- Quality Assurance Managers
- Clinical Directors
- Legal Affairs
- Research & Development
- Risk Management
- Insurance Managers