Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in the drug and medical device industries. Previously she was the founder and the 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, Nancy represented the industry on the working group that conceived 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, Nancy 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. If you have questions about the content of the training, please email Nancy at nancy_singer@compliance-alliance.com.
John Avellanet has spent more than 15 years being accountable for regulatory compliance, most recently as a C-level executive for a Fortune 50 biotechnology and medical device subsidiary. In 2006, John co-founded his FDA management advisory firm, Cerulean Associates LLC. He is the author of more than 100 internationally syndicated articles on simplifying compliance and FDA quality systems, is the compliance columnist for the Journal of Commercial Biotechnology and Pharmaceutical Processing magazine, and a contributing author of the book Best Practices in Biotechnology Business Development (Logos Press). He conducts on-site corporate workshops and online remote webinars for his clients, and has led dozens of training seminars on FDA quality systems, records management, and lean compliance, consistently garnering "excellent" and "Wow" feedback from attendees. Read more about John or contact him at his website at www.ceruleanllc.com.
Marlene Bobka is Vice-President of FOI Services, which she joined in 1985. She is responsible for FOI’s series of educational teleconferences, and is actively involved in the organization and management of FDA information, with a special interest in knowledge management and competitive intelligence. Before joining FOI Services, she served as an Information Specialist at Bibliographic Retrieval Services, designing and supporting databases in science and medicine. She has also served as Information Specialist in the Director’s Office of Cancer Communications, supporting the press and public information outreach departments. She is a frequent author and speaker for a number of industry organizations, including RAPS, the Special Libraries Association, the American Chemical Society, and others. Marlene holds a BS in Biology and Chemistry and an MLS in Medical and Scientific Information from the University at Albany. She can be reached via FOI’s website at www.foiservices.com
Each toll-free (even if international) dial in is $449; put the teleconference on your speakerphone and have as many attendees as you like for this price. FOI Services will provide a handout of about 50 pages approximately two days before the teleconference. The materials may be duplicated for anyone attending.
Tuesday, August 18, 2009, from 1:00 p.m. to 2:30 p.m. EDT (GMT -4)
In your office or conference room
To register online, or for details on additional upcoming teleconferences, go to www.foiservices.com/tc. You may also call 1-800-654-1147 (outside the US and Canada call +1-301-975-9400) to register by phone.