Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries

by Chris Gasiewski

Quality assurance: Problem solving and training strategies for success in the pharmaceutical and life science industriesThe easiest way to build quality, according to Gordon Welty, Ph.D., is to automate the process.

“Then you don’t have to test the process,” the University College lecturer said. “It’s going to do what you want it to do.”

Dr. Welty’s new book, Quality Assurance: Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries (Woodhead Publishing, 2013), is the culmination of his decades of experience. It details how to build quality into the manufacturing process, and how it is necessary to maintain quality and services in the pharmaceutical and life science industries.

The book is divided into three parts with the first discussing the process by which a problem in industry is initially identified. The second covers staff training and the requirements of revised procedures. And the third continues the discussion through key examples.

“Quality assurance builds the control into the process, making sure it is working correctly every step of the way,” Dr. Welty said. “This way you don’t go into damage control.”

Dr. Welty came to Adelphi’s University College in 2010, after having been in the corporate sector for 10 years. His experience was predominantly in higher education, where he was vice chancellor for information technologies at Indiana University Kokomo and a former professor of sociology and assistant dean for computer services at Wright State University.

In 2007, he began consulting on quality management for the pharmaceutical industry, and he previously was manager of good manufacturing practices training at Merck/Schering-Plough and an instructional designer and program manager at Eli Lilly & Co.

“When I went into industry 10 years ago, I had the chance to refine all of these ideas,” he said. “After a while, I just pulled it all together.

“I did some work in the financial services industry as well. An important part of quality assurance is if you want regulators coming in and looking at your process, you’ve got to have a process where you are assured that it is doing quality work.”

Dr. Welty hopes that his ideas and new thinking become the standard in today’s manufacturing industry. His book is already being sold overseas and is projected to be published in the United States this May.

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