Making FDA-Required Training Captivating: Training the Trainer

Presented by Nancy Singer, Compliance-Alliance LLC & John Avellanet, Cerulean Associates LLC
Thursday, April 26, 2012; 1:00pm – 2:30pm EDT (GMT-4)

FDA requires drug and device firms to train personnel in GMPs, QSR, GCPs, advertising and promotion regulations, and fraud and abuse laws...and neglecting this responsibility carries consequences. FDA-regulated firms such as G&W Laboratories, Syntho Pharmaceuticals, Absolute Packaging and many others have been cited for training deficiencies; the resulting Warning Letters are posted on FDA’s website for competitors, Wall Street, the press and the public to read.

Despite FDA's interest in training, today's economic climate means firms are slashing budgets for initial and ongoing education. You may very well find yourself adding a critical new task to your already long list of responsibilities...becoming an effective trainer for FDA compliance.

If you are now responsible for developing and/or delivering training sessions, don't panic! There are easily implemented techniques you can learn in order to help you:

On Thursday, April 26, beginning at 1:00pm EDT, join FOI Services as Nancy Singer of Compliance-Alliance and John Avellanet of Cerulean present a 90-minute teleconference to share proven techniques you can use immediately to develop and deliver interesting, effective training sessions. Be sure your audiences are engaged and excited about quality and compliance – register today!

What You'll Learn:

What You'll Get:

Who Should Attend:

Speakers:

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 for FDA/CMS regulatory requirements. As AdvaMed’s Special Counsel for FDA compliance and enforcement matters, Nancy represented the industry on the working group that conceived the Quality System Inspection Technique (QSIT), and served as 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 this presentation, 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 www.ceruleanllc.com.

Where:

In your office or conference room

When:

Thursday, April 26, 2012; 1:00pm – 2:30pm EDT (GMT-4)

Online registration has closed.
Please call us at 1-800-654-1147 (+1-301-975-9400 outside the U.S. and Canada)
by 12:45 p.m. EDT (GMT – 5) to register.