Good Laboratory Practices (GLP) for Pre-Clinical Testing

This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for GLP testing and compliance. Those attending will get a thorough briefing of the relevance of accurate documentation, calibration and maintenance of instruments and validation of relevant methodologies. 

The course also covers in detail issues involving the roles and responsibilities of the Study Director in planning, supervising and managing pre-clinical studies. Also, the analysis and reporting of study results will be discussed. Also included is a discussion of functions related to quality assurance unit responsibilities and the need to effectively audit laboratory activities and data for regulatory compliance. Successful audits are often a result of good planning and interaction between QA staff and management. This course will cover a range of audit activities (internal and external) including responsibilities and requirements for compliance including those required at collaborator sites, records management, GLP special requirements, archiving of data and inspections.

The roles and responsibilities of Quality Assurance in the control of daily activities, data collection, analysis and archiving of study information will be discussed. The roles of the Study Director and QA in regulatory and client inspections will also be presented.

The course also discusses how to manage regulatory inspections, and how to respond to regulatory findings and audits. Inspection results for sponsoring companies and CROs are included in these discussions.

Dr. Kenneth Cleaver is a highly regarded GLP consultant with over 20 years of industry experience. Since 2001, Dr. Cleaver has taught GLP courses and consulted for a variety of organizations. These include Medtronic, M.D. Anderson Cancer Institute, Exxon-Mobil, Hewlett-Packard and Phillips Oral Care. His experience covers such disciplines as basic research, drug re-formulation, medical device development, contract laboratory testing and environmental studies.

Prior to 2001, Dr. Cleaver served as Vice President of Product Development for Novadel (formerly Flemington Pharmaceutical). Before this, he was a consultant with Medical Development Quality Associates and directed the Quality Assurance Unit at Oread Laboratories – a CRO specialized in distribution, metabolism and excretion of drug substances in various animal species. He has also run several toxicology studies in mice, rats, guinea pigs and dogs for such clients as Upjohn Laboratories, Marion Laboratories, Bristol-Myers Squibb and Burroughs-Wellcome.

Dr. Cleaver received his Ph.D. in Pharmaceutics and M.A. in Organic Chemistry from Temple University. He received his B.S. in Chemistry from Albright College.