We believe that pharmaceutical and medical technology companies create and market safe and effective products. We know that operating under government regulation is difficult, that product liability defense is expensive, and that adverse publicity can be crushing. We help companies change their culture to reduce the risks.
Can Compliance be Taught? Can Training help?
Yes, and it doesn’t imply simply learning the rules. In the medical products industry, employees must know which rules matter, and why. There are new rules all the time. Professionals must distinguish which are important. They can use our training to help them.
They write. They speak. They meet. Our training helps them communicate more effectively in each mode.
Better Communicators are Better Employees
Compliance-Alliance creates seminars that improve employees’ communication about regulatory compliance, and stimulate thinking about the seriousness of their work.
Communication Training Has to be Fun
It doesn’t work if it is dull or boring. When training is interactive, relevant and in-person, the experience is fun. People participate, learn and remember.
We’ve been traveling to medical product companies to present interactive training for over ten years. Reactions from groups as small as five and as large as a hundred have been positive and rewarding. In the past five years, FDA has become a significant customer. The industry wants to know what we have been teaching the regulators, and we are happy to comply.
Research and Development
We do our own research on verbal and written communication. We develop our own materials and seminars. We do extra work to incorporate some of the customer’s documents in order to enhance interest and pertinence. Having the time to customize a seminar to a particular occasion adds value to our ability to ascertain and meet customer needs.
Regulatory compliance can improve along with improved communication skills. When people participate in the training, they learn the why and the how, and they improve their skills.
Nancy Singer founded Compliance-Alliance LLC in 2004 to help professionals employed in the drug and medical device industries establish a culture of compliance. Previously she was the founder and Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provides training on FDA/CMS regulatory requirements. She also served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Singer was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process.
She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry.
Before joining AdvaMed, Singer was the Executive Director of the Food and Drug Law Institute. Her career began as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Singer received her B.S. from Cornell University, and J.D. and LL.M. degrees from New York University Law School. During her career, she taught food and drug law at Catholic University Law School and George Washington University Law School. She chaired the Food and Drug Law Section of the Federal Bar Association, and retired as a Commander in the United States Naval Reserve. Singer’s email address is firstname.lastname@example.org.
While working on QSIT and the FDA/Industry Grass-Roots Task Force, Singer received Vice President Gore’s Reinventing Government Hammer Award. She received the FDA Commissioner’s Special Citation on two occasions.
Singer also received:
- Distinguished Service and Leadership Award from the Food and Drug Law Institute
- Leadership Award in 2010 and 2014 from the Association of Food and Drug Officials
- RAPS Special Recognition Award in 2011 from the Regulatory Affairs Professional Society
- 100 Most Notable People in the Medical Device Industry
- AdvaMed Award of Merit
- Food and Drug Law Institute Fellowship
- Martha Van Rensselaer Scholar