Cerulean’s John Avellanet and FDA’s Kim Trautman interviewed on Environment Controls. FDA reminds device companies that they must control environmental conditions for both products and manufacturing facilities, or risk tough regulatory penalties. “Clearly environmental controls are important, and FDA will … Continue reading →
Cerulean Associates LLC has been chosen as the independent review organization (IRO) for a major consent decree. The consent decree, between the US Department of Health and Human Services, the Office of Inspector General and the Wisconsin medical device firm … Continue reading →
Data integrity is a recurring theme in noncompliance and whistleblowing cases. Long after a drug has gone off patent, the data associated with that drug show how well its manufacturer controlled its processes, ran its operations, and met FDA’s regulations. … Continue reading →
The BiotechBlog interviewed Cerulean’s John Avellanet about the success of his book, Get to Market Now! Positive reviews of the book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, have been … Continue reading →
Companies considering virtual suppliers must first make sure their supplier qualification processes can handle such businesses. There are two common pitfalls for companies dealing with virtual suppliers: not recognizing they are probably already doing business with one, and not being … Continue reading →
How responsible should the sponsor be for the outsourcing provider’s success? When assessing the competencies of an outsourcing service provider such as a contract manufacturing organization (CMO), sponsor companies must pay a great deal of attention to the cGMP compliance … Continue reading →
Remember what you said about those test results in that email to your team on Tuesday afternoon…six years ago? Neither did executives from Pfizer, Merck, and other firms recently taken to court and forced to publicly disclose millions of emails … Continue reading →
Virtual consultants, also known as teleconsultants, have transformed the traditional view of the consulting field. One is no longer stuck playing host to a mixed team of experienced experts and junior consultants. Today, you can pick a senior consultant to … Continue reading →
A collision between technology and regulation is fast approaching. As pharmaceutical, biotech and device companies – and their suppliers – look for ways to cut costs, technology is leaping to the forefront. Leading the pack is the idea of outsourcing … Continue reading →
In a tight global economy, with pharmaceutical companies facing a steep revenue decline over the next two years, IT needs to improve its image – something that will be increasingly difficult as companies trim capital investments and IT budgets face … Continue reading →
