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Q. I’m responsible for quality at a small, virtual startup company, and we contract out all of our activities. I’m working on documentation to contract out our product testing and...

With the rapid evolution of technology, more and more companies in regulated industries have transitioned to an electronic medical device audit trail. This was the impetus for the U.S. Food...

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of ÃÛ¶¹ÊÓƵ Compliance Associates, discuss how to write standard operating procedure that holds up to...

Critical insights into the complexities and pitfalls of mergers and acquisitions (M&A) and carve-outs in the pharmaceutical industry highlight the necessity of comprehensive regulatory and technical due diligence. Neglecting to...

Q. I am a quality assurance professional working for a small start-up company. I am setting up their quality management system, but I have little experience with complaint handling or...

This FDAnews virtual summit webinar can empower your team to develop a world-class QMS by implementing the essentials of quality management maturity (QMM) metrics. Additionally, you’ll understand more about the...