The FDA’s approach to enforcing product safety and efficacy is evolving when it comes to CMOs and CROs. 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, and 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.
Price: $399 ($50 with Discount Code 101250)
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
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.