John G. (Jerry) Lanese, Ph.D. CMC is the president of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.
In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. Recorded
Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. Recorded
Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s and expanded as an international expectation for the industry with the publication of ICH Q2 in the mid 1990s. Recorded