FDA Do's & Don'ts for Selecting, Qualifying & Managing Suppliers in a Global Economy

Presented by John Avellanet, Cerulean Associates LLC
Thursday, August 12, 2010; 1:00pm – 2:30pm EDT (GMT -4)

To avoid shutdowns, seizures, and warning letters, your drug or device firm needs effective purchasing controls which balance business constraints with FDA requirements.

Increasingly, the global economy is pointing FDA’s scrutiny toward how regulated industry manages suppliers and the compliance controls being used. Earlier this year, John Avellanet, based on his decades of working in and with drug and device companies, taught FDA officials about the essential elements of a cost-effective FDA and ISO-compliant supplier selection, qualification and oversight program.

Now, you can hear what FDA management learned about your supplier management, and discover which aspects of this process provoked the most interest, concern and questioning – information sure to be considered in your next inspection.

On Thursday, August 12 at 1:00pm EDT, join FOI Services and John Avellanet for a 90-minute teleconference examining the points of interest to FDA in your supplier selection, qualification, and monitoring – and how you can establish procedures to effectively and efficiently manage these aspects of your regulatory compliance burden.

What You'll Learn:

• The top supplier challenges biopharma and device firms face in a global economy
• An effective, systematic strategy for selecting, evaluating, and qualifying suppliers
• Techniques for getting suppliers to share the compliance burden
• Methods for ensuring vendor accountability
• The types of suppliers with whom FDA expects drug and device firms to have quality agreements
• The risk for firms if their SOPs state "quality agreements are required for all OEM suppliers."
• Key components of a supplier qualification program that FDA investigators expect to see
• Comparison of FDA's purchasing controls with the requirements of ISO 13485
• When firms should be performing on-site supplier audits
• How using ISO certification as the basis for supplier qualification can get firms in trouble
• Techniques to get a better response rate from "paper" or mail-in supplier questionnaires
• Methods for prioritizing suppliers based on risk
• How to address second-tier suppliers
• What an FDA inspector will be looking for when it comes to vendor management
• Recent FDA expectations toward managing contractors, and consultants

What You'll Get:

• A checklist of do's and don'ts for supplier agreements
• A supplier short-form questionnaire template
• Two case study article reprints
• An opportunity to receive, without charge, a six-month trial subscription to Mr. Avellanet’s private newsletter, SmarterCompliance
• An experienced and approachable instructor
• Time for questions and answers

Who Should Attend:

• Management and staff in R&D, preclinical, manufacturing, regulatory affairs and quality control and assurance
• Vice presidents, directors, and senior managers of pharmaceutical, biotechnology, and medical device companies
• Biotechnology and device startup management teams
• Contract manufacturers, research organizations, and distributors responsible for supply chain quality
• Supply chain and purchasing professionals

About Your Instructor:

John Avellanet, author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press), is the founder and managing director of Cerulean Associates LLC. His clients include Fortune 50 biopharmaceutical firms, medical device startups, and everything in between.

Mr. Avellanet has gained tremendous acclaim for his speeches, workshops, and business-savvy compliance consulting work with corporate clients and conference venues 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.”

Learn more about Mr. Avellanet or the content of this teleconference 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.

How It Works:

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 approximately 1-2 days before the teleconference. The materials may be duplicated for anyone attending.

When:

Thursday, August 12, 2010; 1:00 p.m. to 2:30 p.m. EDT (GMT -4)

Where:

In your office or conference room

To Register:

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 U.S. and Canada call +1-301-975-9400) to register by phone.

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