This GLP training 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.
The GLP regulations contain many specific duties for Study Directors. This course will explore in detail the numerous requirements and expectations of Study Directors for both internal and contracted studies. The regulations for Study Directors are unique to GLP, when compared to other quality standards.
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.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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. It ensures the consistency and reliability of results for submissions to the USFDA, 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 pre-clinical studies. 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, medical device, biological, 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 the 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.
Frequently Asked Questions
I hear that GLP is just like GMP for laboratories. Is this true?
They are similar in many ways, especially in the area of documentation. However, GLPs focus on the reliability of data that is generated during the development of potential products during research studies, while GMPs focus on the reproducibility of products, either near the end of the research effort or after the product has been approved for marketing.
Can the Quality Assurance Auditor be part of the technical staff that performs the study?
No! The GLP Regulations clearly state that Quality Assurance must be independent from the Study Director. Since the Study Director supervises the technical performance of the study, the Auditor cannot be part of the study group. A government inspector always checks to be certain that QA is independent from the study group.
Must Quality Assurance Audit findings and corrective action be shown to an FDA inspector?
No, they do not. An inspector can ask to see audit findings, but audit reports do not have to be presented. A Sponsor must show proof that studies, facilities and data were audited at appropriate intervals, but actual findings can be withheld.