How to Help Your CMO or CRO Pass an FDA Inspection – March 30th, 2011

How to Help Your CMO or CRO Pass an FDA Inspection – March 30th, 2011

March 25th, 2011 // 1:30 am @

How to Help Your CMO or CRO Pass an FDA Inspection – March 30th, 2011

How good are Avellanet’s Webinars? So good that Webinar registrants become his clients:

“It was a pleasure listening to your webinar on 21 CFR Part 11 this week. I spoke with management and they are interested in your assistance with our SAP validation.”

FDA is increasingly holding both sponsors and contract organizations responsible for a product’s safety and effectiveness. Whether in clinical trials or in the post-market stage, patient safety is the #1 driver for FDA enforcement. So how do you ensure your CMO or CRO can pass an inspection centered around your product? And will the agency only inspect the contracted manufacturer or trial monitor … or are there reasons why the inspector will visit you first?
Join supplier compliance expert, John Avellanet, as he walks attendees through the FDA’s evolving approach to enforcing product safety and efficacy when it comes to CMOs and CROs. Learn how to strike a defensible balance between supplier oversight and contracted outsourcing. Get expert experience and advice on protecting yourself – and your contract partners – from regulatory enforcement, financial loss, and litigation.

Over the past 16 years, Mr. Avellanet has become a leading international expert on FDA regulatory compliance and taking advantage of cutting-edge techniques to bring new products to market and achieve cost-effective compliance. In his career, Mr. Avellanet has learned hard lessons on how to evaluate and manage critical suppliers – and how to avoid hidden pitfalls. His acclaimed book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, has been repeatedly praised for its business-savvy advice and practical tips, giving readers a productivity advantage in today’s economy.
Now, exclusive to Expert Briefings, Mr. Avellanet, brings a review of the FDA’s latest strategy for ensuring product safety through contracted suppliers. Join us on May __ for a practical run through of how to stay on top of this evolving enforcement trend.

What you’ll learn:

• Reasons why the FDA is now looking at both the contractor and sponsor
• What the agency looks for when inspecting both the CMO/CRO and the sponsor
• A three-point lean compliance strategy for you and your CMO/CRO
• How to prepare your CMO/CRO for an inspection of your product
• How to support your CMO/CRO during the inspection
• How to help the CMO/CRO respond to the inspection
• An eight-step lean compliance critical supplier audit strategy

This webinar will give you a set of tried and true 21st century techniques to improve compliance, maximize productivity, and lower risk.

What you’ll receive:
• A detailed list of the SOPs, forms and policies you’ll need
• List of FDA, ICH and GHTF guidance documents to rely upon
• An example supplier questionnaire
• (insert the usual stuff from Expert Briefings)
• Four risk-free trial issues of the FDA regulatory intelligence newsletter, SmarterCompliance

Who should attend:
• Regulatory affairs professionals
• Quality management executives
• Supplier management and procurement professionals
• Chemistry and manufacturing controls directors
• Clinical trial planners and managers
• Compliance and records management professionals
• Supplier audit teams
• Anyone interested in using regulatory intelligence to ensure compliance currency

Attendees will receive these free gifts:

3-month subscription to FDA Digest – 483/warning letter e-newsletter
Complimentary recording of the event
3-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
“Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)
About the Presenter

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.”

You can learn more about Mr. Avellanet through his independent advisory firm, Cerulean Associates LLC, on the web at, or through his award-winning blog at


Live GotoMeeting Webinar: $399.00

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"His voice is like a honey-sweetened mix of Fergie and a cherub's trumpet. I just melt during John's webinars.

-Sarah Jones, ABS Pharma "

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