CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
December 3 - 5, 2018
Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)
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.
PLEASE NOTE: Proposed changes to the GLP Regulations were published by the FDA on August 25, 2016 and will be discussed. The FDA will be accepting comments to the proposed changes for 120 days and will eventually publish all questions/comments with responses at some future date.
Major changes between the current regulations and the proposed revisions include significantly greater involvement of management in the quality system, the requirement to have a risk management program, control of electronic information and control of subcontracted services.
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.
This three-day GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who are active in regulated laboratory studies. It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of laboratory data to regulatory agencies. Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from this 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, medical device, 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. The course will also benefit professionals from CROs that operate under the GLPs.