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Challenges of FDA Supplier Qualification of Virtual Companies

Audio conference highlights:

The Heparin scandal of 2008 exposed a painful gap in FDA and the industry’s supplier management strategy: the inability to handle companies in the supply chain that have no physical presence – so called “virtual suppliers.” In 2010, Congress sent FDA a letter detailing concerns about how FDA was not enforcing industry’s use of suppliers who turned out to be virtual companies. FDA called the use of virtual suppliers in the Heparin scandal a “wake-up call” to the industry and began to step up enforcement.

Over the past year, FDA has increased supplier control training for its investigators, particularly around how companies should qualify and monitor virtual suppliers and virtual manufacturers. How will you answer these FDA investigator questions? How are you determining which of your suppliers is a virtual company? How are you qualifying and monitoring those virtual suppliers?

In this presentation our speaker explains current FDA expectations of supplier oversight and control in a global landscape, as well as techniques to determine if a supplier is a virtual company, red flags to be aware of that can lead to a warning letter, an import hold or worse, and how to ensure that your virtual company oversight efforts are effective in the eyes of the FDA. Attendees will receive a detailed handout and a list of specific supplier-control regulatory documents used in FDA investigator training.

This audio conference covers:

  • Key components of a virtual supplier program that will pass FDA inspection
  • What to do when onsite supplier audits are not an option
  • Specific metrics that demonstrate effective oversight of virtual companies as suppliers
  • Red flags to be aware of – and how to build checks against them into your processes
  • The two most common types of virtual companies

About the speaker:

John Avellanet is an internationally renowned speaker and authority on lean compliance topics of supplier management. He spent 15 years personally accountable for regulatory compliance and vendor oversight, most recently as a C-level executive in a combination biopharmaceutical and device Fortune 50 subsidiary. Since founding Cerulean Associates LLC in 2006, he’s traveled around the world helping clients and solving problems with practical, innovative solutions to strengthen compliance while lowering costs and reducing risk. In 2010, Mr. Avellanet trained FDA and Health Canada directors on best practices in other industries to qualify and oversee virtual and global suppliers. Mr. Avellanet has been interviewed on multiple radio programs and in media podcasts, and his most recent book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, was featured at BIO 2011.

Who should attend?

  • Quality assurance directors and managers
  • Purchasing and supply chain professionals
  • Supplier oversight
  • Contract manufacturers
  • Regulatory professionals

Product Details

John Avellanet, Cerulean Associates LLC
Challenges of FDA Supplier Qualification of Virtual Companies
Title: Managing Director & Principal
Duration: 60 minutes
Event Type: Previously recorded on 2012-05-23
Item #: ac20120523
23 May 2012 
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