Jerry Lanese
The Lanese Group, Inc., USA
Biography
John G. (Jerry) Lanese, Ph.D, is an independent consultant in the area of quality systems, quality management and FDA regulatory compliance. He has more than thirty years of experience in quality systems, quality system development, quality system audits, method development, quality control laboratory management, quality assurance, regulatory compliance and training. Jerry has a thorough knowledge of Baldrige Criteria, FDA Quality System approach, Quality System Regulation, ISO 13485, analytical instrumentation, product testing, specification development, validation, documentation review, GMPs, and quality management concepts. Jerry is currently the co-editor of GXP Talk, a continuing series of articles that appears in the Journal of Compliance.
Abstract
Abstract : Turning the FDA quality metrics into a proactive quality improvement tool