Paul Swidersky is the founder and former president of Quality Associates, Inc. (QAI). In his current role as executive director of QAI’s Quality Assurance & Scientific support division, Swidersky is responsible for the overall management and direction of the division. He has more than 40 years of experience in the scientific research area.
Prior to founding QAI in 1986, Swidersky spent a decade working at the University of Maryland School of Medicine’s Pulmonary Disease Division, where he participated in clinical research. His past and current quality assurance (QA) experience covers all aspects of QA work under the FDA, EPA, and OECD Good Laboratory Practice (GLP) regulations, plus FDA/ICH Good Clinical Practices (GCP).
Swidersky has presented papers at national scientific meetings, established and implemented GLP compliance programs both nationally and internationally, conducted many research laboratory quality training seminars, and acted as a liaison between client and government regulatory agencies. His quality assurance experience has included all study types (mammalian toxicology, ecotoxicology, biotechnology, analytical/bio-analytical chemistry, field trials, etc.) for regulatory submission. Swidersky’s GCP experience involves CRO and PI site qualification audits, protocol reviews, study site audits, database audits, report audits, etc.
Swidersky holds a bachelor’s degree from Shenandoah College, an Associate of Arts degree in respiratory physiology in Community College of Baltimore, and an Associate of Arts degree in electrical and electronic engineering from Pennsylvania State University.