JVT Journal Articles
Vol. 13, Issue 4, Nov 2007

Jerry Lanese, Ph.D.
Nineteen-seventy-six was the bicentennial year for the United States. It was also the eve of the planned issuance of new Good Manufacturing Practice (GMP) regulations in a number of areas regulated by the Food and Drug Administration (FDA). These included the revised GMP for pharmaceutical products1,2, a new GMP for medical devices3, as well as a...
Timothy J. Fields
On October 26, 2006, the pharmaceutical community lost one of the giants in the areas of quality and validation, Kenneth G. Chapman. Many of those new to the Pharmaceutical Industry may not realize that a number of the concepts being discussed today are similar to the con- cepts and approaches proposed by Ken Chapman approximately 30 years ago.
William Hall
Sir Isaac Newton once wrote that we all "stand on the shoulders" of those many people who came before us. One of those people was Ken Chapman. Ken was a man short in stature, but a giant in his profession and a true gentleman. I still remember the first time I met Ken when I was a young man eager to learn and attending a meeting in...
Not all software validation projects are created equal. Though this statement is obvious to any team leader or consultant who has executed software validation in an FDA-regulated company, it can be difficult to grasp for managers more concerned with production schedules and challenges than with validation, and especially for managers in...
Miguel Montalvo
The concept of Process Validation (PV) has evolved during the last 30 years and will continue to evolve in the future as our industry matures and the regulatory agencies move toward implementation of quality systems, Quality by Design (QbD), and global harmonization. The area of Process Validation was near and dear to Mr.
Timothy J. Fields
International Conference on Harmonization (ICH) Q8, Pharmaceutical Development1 was finalized in November 2005 and introduced the concept of “Design Space.” The idea of defining criteria within which one must control a process to ensure that a quality product is produced is not a new concept. The late Ken Chapman proposed the precursor to the...
Robert W. Stotz, Ph.D.
The author first met Mr. Chapman in June 1987 as a new member of the PhRMA's (formerly the PMA's) Computer Systems Validation Committee (CSVC) which had reconvened to address the source code issue1 and eventually launch the “Staying Current” series of articles.2 This was the start of a long term collaboration between Mr.

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