This first two days of 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 methodology. Special attention will be paid to the critical compliance aspects of gathering pre-clinical data in a regulated environment.
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 third day of the course will cover in greater 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. 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.
Who Should Attend
Good Laboratory Practices (GLP) generally refer to a quality system of management controls for laboratories and research organizations that regulate how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. It ensures the consistency and reliability of results for submissions to the USFDA, the OECD and other national organizations.
This three-day course is designed for all scientists (managerial and laboratory), regulatory affairs and compliance personnel who are active in pre-clinical studies and in other laboratory settings. It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of data from pre-clinical studies. Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from the course.
This course is also useful for quality assurance and quality control managers, coordinators of multi-site projects, regulatory affairs professionals, auditors, and senior management interested in effective QA techniques. New and experienced staff from the food, pharmaceutical, nutraceutical, agrochemical and cosmetics industries will learn the fundamental principles and applications of GLP, particularly in the complex multi-site environments of today’s industry.
By the end of this three-day course, attendees will have a strong understanding of the fundamental compliance requirements for current Good Laboratory Practices, and will be able to apply compliance protocols in all efforts aimed at generating regulated data for evaluation by the US FDA and regulatory agencies overseas. All participants will gain a fundamental understanding of the basis of the regulations and the necessity of rigorous implementation. Special attention will be given to incorporating proactive thinking and a robust compliance regimen in all scientific matters. The consequences of non-compliance will be examined, including a thorough review of examples of previous FDA inspectional findings.