My career began as an attorney with the United States Department of Justice where, during a three year period, I successfully prosecuted seven firms for violations of various criminal statutes. Subsequently I was a partner at the law firm of Kleinfeld Kaplan and Becker. I received my B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School. During my career I was an instructor at Catholic University Law School, George Washington University Law School, University of Southern California, and at compliance symposia at Harvard University. I created Compliance-Alliance LLC to specialize in professional development for those employed in drug, device and other manufacturing industries. In addition to other successful courses, I developed the course, “Dangerous Documents” when I was employed as General Counsel for a drug and device firm and have been presenting it to both individuals and groups with resounding success for more than eight years. I 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. In 2009 I was selected as one of the 100 Most Notable People in the Medical Device Industry. I am a retired Commander in the United States Naval Reserve.Specialties: Interactive training on risk avoidance writing. Legal and regulatory advice on compliance with FDA requirements for drugs and medical devices.
