FDA officials are increasing their scrutiny of how firms control their supply chain – from contract manufacturers, contract research organizations, material suppliers and even professional services.  To avoid costly shutdowns, product seizures, and warning letters, companies need to minimize their risks from sloppy suppliers and noncompliant vendors.

Building, maintaining, and overseeing a supplier monitoring program has never been more challenging and is getting more difficult all the time.  Yet you can master it with training by an expert.

This webinar will show you how to put in place a risk-based supplier monitoring program, align controls with your business strategies and capabilities, and reduce your risk of product liability lawsuits and failed inspections.

YOU WILL LEARN:

·    What is – and is NOT – working when it comes to overseeing suppliers

·         Key tactics to share the compliance and quality system burdens

·         The hidden dangers in how suppliers manage your required records

·         What the inspector will look for when it comes to your oversight of suppliers

·         Specific regulatory harmonization guidelines you can put to work today

·         How to develop a documented, repeatable risk evaluation matrix for suppliers that meets FDA expectations and aligns business capabilities

·         How to translate supplier risk evaluations into practical controls

·         CEOs, Presidents, Vice Presidents, directors, and senior managers of pharmaceutical companies

·         Biotechnology and device startup management teams

·         Contract manufacturers, research organizations, and distributors responsible for supply chain quality

·         Executives in R&D, preclinical, manufacturing, regulatory affairs, and quality management

·         Supply chain and purchasing professionals

Mr. Avellanet will give to each participant a four-month trial subscription to his private newsletter for his clients, SmarterCompliance, full of quality system tips and regulatory intelligence.

John Avellanet, author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press), helps clients solve compliance problems.  He is the founder and managing director of Cerulean Associates LLC, a lean compliance consulting firm.  An internationally acknowledged expert who has trained FDA, NIH and Health Canada officials on supplier management issues, his clients include Fortune 50 pharmaceutical firms, biotechnology startups, and everything in between.

Mr. Avellanet has gained tremendous acclaim for his speeches, corporate workshops, and business-savvy compliance consulting work around the world.  One CEO recently commented,

“I would go out of my way to hear John speak on any subject just to enjoy his style of message delivery.  He speaks with a brilliant combination of energy, humor, positive attitude, and solid meat-on-the-bones details.  Just perfect.”

You can learn more about Mr. Avellanet through his independent advisory firm, Cerulean Associates LLC, on the web at http://www.Ceruleanllc.com, or through his award-winning blog at http://www.ComplianceZen.com.

* 90-minute webinar (Travel-Free) delivered over the phone and Internet.
* Unlimited listeners per connection - bring the entire department.
* Q&A session with the expert.

This event will be presented live by phone together with a PowerPoint presentation to be viewed on your computer. Internet access is not required for phone-only participants. The PowerPoint slides will be provided shortly before the event. Once you register, you will receive an email which is your receipt and which includes your instructions for dialing in and logging on. You will also receive an email reminder 24 hours before the webinar.