Event Information
BIOCOM Christmas Breakfast
Join your colleagues for the BIOCOM Holiday Breakfast Meeting and participate in an entertaining, interactive session entitled, "Dangerous Documents: Helping Your Company Avoid Land Mines in FDA Records and Emails."
As is our tradition, our December breakfast meeting will lend some comedic relief to your busy holiday. Don't let innocent emails or communications taken out of context highjack your company. You have enough to worry about with the FDA without fretting about how company emails could undermine the credibility of your organization or cost the company millions of dollars.
We'll take a look at how high profile individuals have fallen prey to misconstrued communications and demonstrate how to avoid that fate in your own organization. In this hands-on program, led by industry expert Nancy Singer (formerly a prosecutor and defense lawyer), and Joleen Schultz (communications expert with Mentus Life Science), you will have opportunities to analyze improperly written documents and revise them to reflect your firm's commitment to quality. You will leave the meeting with practical information that will benefit you and your company for years to come.
Topics to be covered include:
-Who can be held criminally liable under the Federal Food, Drug, and Cosmetic Act
-How to distinguish between fact and opinion
-The wrong way to construct meeting minutes
-Problems with cryptic emails
-Words that will attract prosecutors' or plaintiff's lawyers' attention
-How to build a program to avoid dangerous documents
You won't want to miss this session that has been presented nationwide to large and emerging companies AND the FDA!
Information about the presenters:
Nancy Singer founded Compliance-Alliance LLC to specialize in the professional development for those employed in the drug and device industries. Singer's legal career began as an attorney with the United States Department of Justice where she represented the FDA in criminal and civil litigation. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. During her career she served as special counsel to AdvaMed. She also was an instructor at Catholic University Law School, George Washington University Law School, University of Southern California, and at compliance symposia at Harvard University. Singer received her B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School. She received Vice President Gore's Reinventing Government Hammer Award, the FDA Commissioner's Special Citation, and the Food and Drug Law Institute's Distinguished Service and Leadership Award. Singer is a retired Commander in the United States Naval Reserve.
Joleen Schultz, Principal, Mentus Life Science Joleen is a branding and marketing expert with over 20 years experience in the medical device, healthcare and pharmaceuticals industry. Joleen has been instrumental in positioning companies and products for accelerated success in the marketplace. She received her B.S. from Purdue University and her Masters degree from San Diego State University. Joleen currently chairs Biocom's Medical Device committee.
| When | Friday, December 3, 2010 7:00 a.m. - 9:00 a.m. |
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| RSVP | Thursday, December 2, 2010 12:00 p.m. |
| Where |
Hyatt Regency La Jolla 3777 La Jolla Village Drive San Diego, California 92122 |
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