Op Ex & Lean Six Sigma / QRM Process

Mark McClellan on Pharma’s Role in U.S. Health Care System

Speaking at a Sept. 19 conference at Glatt Pharmaceutical Services, former FDA Commissioner Mark McClellan reminded pharma manufacturing professionals why their work is a critical part of the national health care debate.

In addition, McClellan emphasized the impact that new manufacturing methods and innovations such as controlled release formulations are having a measurable impact on the quality of human healthcare, improving the treatment of chronic pain (with opioids), cardiovascular disease, high cholesterol and ADD. He also discussed modernization and the use of Quality Systems within FDA and the industry.

During the question-and-answer period, one individual — perhaps one of many in the pharmaceutical industry who may forever associate McClellan with his quote in the Wall Street Journal a few years ago about drug makers being behind potato chip and soap flake manufacturers in their use of manufacturing science — asked the former commissioner to assess Agency progress so far. Tune in for his response.

Click here to access the audio file of McClellan's complete presentation — including the Q&A period.

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