Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies
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Course Fee
$2650.00 Regular Registration
$2450.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
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Course Description
This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for conducting a study in compliance with GLP regulations. 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 Test Site Management and the Study Director in planning, supervising, and managing nonclinical studies. The requirements for training of staff, good documentation practices, study protocols and reports, and standard operating procedures will be examined. Requirements for equipment such as qualification (installation, operational, and performance) and maintenance will be discussed. The special requirements for the facilities including the archives will be discussed. The requirements for the conduct of the GLP compliant laboratory study to assure animal welfare, data integrity, and thorough chain-of-custody of specimens and materials will be discussed.
Also included is a discussion of the functions of the Quality Assurance Unit (QAU) and the need to effectively audit laboratory activities and data for compliance to GLP regulations and internal SOPs and test methods. Successful audits are the result of good planning and effective communication between QA staff and management. This course will cover a range of audit activities that must be conducted to assure management that laboratory studies are performed in compliance to the regulatory standard stated in the study protocol.
The responsibilities of Quality Assurance in the monitoring of laboratory activities during 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 findings of non-compliance noted during a regulatory agency inspection. Inspection results for sponsor companies and CROs are included in these discussions.
Who Should Attend
Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how nonclinical 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 testing of specimens from pharmacokinetic and other clinical studies. This ensures the consistency and reliability of results for submissions to the US FDA, US EPA, and other national regulatory agencies.
This 20 hour GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who actively participate 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 GLP regulations.
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Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.