Compliance directors, CFOs and quality managers now have a proven strategy to control risks associated with their supply chain according to a new article published in the March edition of the peer-reviewed BioProcess International journal, “Shared Risk: A Regulatory Management Strategy.”

Part of Cerulean’s Lean Compliance strategy, the article uses client case studies and the personal experiences of Cerulean’s co-founder, John Avellanet, a former medical device executive, to discuss several core tactics to Cerulean’s Lean Compliance approach when it comes to vendor selection and management:
1. Strategic supplier selection using Cerulean’s Strategy-Impact Matrix
2. Contractual tactics
3. Mistakes to avoid (that often seem like good ideas at first)

“Given the entire Heparin mess, we decided to publish the strategy to give executives a chance to adopt this and quickly achieve a peace of mind,” said Mr. Avellanet. “In fact, I’ve recently been asked to serve on an FDA panel in September to discuss ways to more broadly apply this across the pharmaceutical and biotech industries.”

For non-BioProcess International subscribers, Cerulean will make a free reprint of the article available next month in the Resource Library of the Cerulean website.

Mr. Avellanet is an internationally recognized expert, business adviser and syndicated author on cost-effective regulatory compliance. He publishes the monthly executive newsletter SMARTERCOMPLIANCE™, and is the compliance columnist for the international Journal of Commercial Biotechnology.

Cerulean Associates LLC (ceruleanllc.com) is a small, private compliance consulting company that helps clients achieve cost-effective lean compliance, prevent intellectual property theft and streamline their quality systems.