Good Laboratory Practices (GLP) for Pre-Clinical Testing
Course Description
This course will provide participants with an understanding of the terminology, regulations and mandated practices for GLP testing and compliance. The course also covers:
- Issues involving the roles and responsibilities of the Study Director in planning, supervising and managing pre-clinical studies
- The analysis and reporting of study results
- 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.
Who Should Attend
Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. Many Bioanalytical laboratories have also chosen to follow GLP as the quality system for the control of testing for pharmacokinetic and other clinical studies. This ensures the consistency and reliability of results for submissions to the USFDA, USEPA, the OECD and other national organizations.
State funding may be available to attend this course thanks to our partners at West Chester University. For more information, visit http://www.wcupa.edu/externalOperations/cpe/WEDnet.aspx] or contact Mary Lou Doyle at [email protected]
COURSE AGENDA
Section 1: Introduction
Section 2: The Regulations - 21 CFR 58
Section 3: It Starts at the Top - Organization, Management & Documentation:
Section 4: Implementing GLPs
Section 5: Study Director
Section 6: Quality Assurance
Section 7: Regulatory Inspections
Section 8: Emerging Issues
*Lunch will be provided
Course Director
Dr. Kenneth Cleaver is a highly regarded GLP consultant and has over 20 years of industry experience in a variety of settings.
Since 2000, Dr. Cleaver has taught GLP courses and consulted for a variety of organizations, including Medtronic, M.D. Anderson Cancer Institute, Exxon-Mobil, Hewlett-Packard, Phillips Oral Care and Vertex Pharmaceuticals. This includes a wide array of disciplines, including basic research, drug re-formulation, medical device development, contract laboratory testing and environmental studies.
Prior to that he directed the Quality Assurance Unit at Oread Laboratories, a Contract Research Organization (CRO) that specialized in distribution, metabolism and excretion of drug substances in various animal species and also ran a wide variety of basic toxicology studies in mice, rats, guinea pigs and dogs. Companies which ran GLP studies at Oread included Upjohn Laboratories, Marion Laboratories, Bristol-Myers Squibb, and Burroughs-Wellcome.
Dr. Cleaver was granted an M.A. in Organic Chemistry and a Ph.D. in Pharmaceutics, both from Temple University in Philadelphia, Pennsylvania.
Questions? Contact Melissa Irwin: [email protected]
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