Editor’s note: KR Karu will be the guest on Quality Digest Live this Friday, June 22, 2012, at 11 a.m. Pacific.
Recently, Janet Woodcock, M.D., the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), criticized the pharmaceutical industry’s lack of commitment to quality management during a presentation at a joint FDA and International Society for Pharmaceutical Engineering (ISPE) meeting in Baltimore. “Pharmaceutical quality management is lacking, and we are not anywhere near where we need to be,” she said. “The whole mantra of the quality revolution is to meet customers’ needs, and that drives everything.”
Although this sounds like a blanket indictment for the pharmaceutical industry, managing quality is not an insurmountable problem. In fact, many companies in the pharma industry already have the tools in place to build a world-class system. However, for too long, quality management has been viewed as a cost center and a necessary burden for companies in highly regulated industries rather than an integrated system that brings processes together and better provides the tools needed to manage quality issues.
What has often been missing is a vision on how to assemble the tools into a comprehensive, integrated enterprise quality management system that enables companies to globalize their quality systems into powerhouses that meet regulatory scrutiny, improve product safety, protect the lives of their customers, and create efficiencies that provide measurable and substantial savings.
Join me for a free webinar at 2 p.m. EDT on June 26, 2012, where I will discuss how enterprise quality management systems bring processes together on a global basis, integrate systems to create transparency and effective and timely decision making, and how improved quality creates not only safer products, but also efficiencies and measurable cost savings.
Here’s the quality system challenge:
Disparate processes
PLUS
Decentralized point solutions
Register online.
KR Karu, the industry solution director at Sparta Systems Inc., works with pharmaceutical companies to identify trends in the global regulatory and business climates. He has more than 25 years of experience helping develop technology solutions that meet quality and compliance needs in the pharma industry. Karu has been responsible for the implementation of enterprisewide quality management systems in most of the top 25 pharmaceutical companies. He is a subject matter expert on FDA regulations, and he’s been a speaker at many industry events.
