John Avellanet spent over 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, Mr. Avellanet 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 for Pharmaceutical Processing magazine. He conducts on-site and remote corporate workshops for his clients, and has led dozens of training seminars on FDA quality systems, records management, and lean compliance. He has a straightforward and real-world teaching style, consistently garnering "Excellent" and "Wow" evaluations from attendees.
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, the educational entity within AdvaMed established to provide training on FDA/CMS regulatory requirements. She also served as AdvaMed's Special Counsel for FDA compliance and enforcement matters. Notably, in her role as Special Counsel, Nancy represented the industry on the working group that conceived the Quality System Inspection Technique (QSIT) and later 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.
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.
Wednesday, September 23, 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.