According to the FDA, CFR part 58, good laboratory practices (GLPs) are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.
As per the FDA, GLPS are for non-clinical laboratory studies in which test articles are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals. GLPs are not enforceable by law. They do not include the manufacturing of the product. However, it is important to be able to compare and contrast GLPs with GMPs and understand their requirements.
Join this session, where expert speaker Joy McElroy will compare and contrast between good laboratory practices (GLPs) and good manufacturing practices (GMPs). She will discuss the objective behind GLPs and how they associate with GMPs and SOPs, and the consequences of non-compliance.
Areas Covered in the Session :
Understanding good laboratory practices (GLP)
GLP as an FDA regulation
Definition of GLPs
History of GLPs
Why were GLPs created?
Objectives of GLPs
Mission of GLPs
The objective of GLPs and how are they associated with GMPs and SOPs
Statistical procedures for data evaluation
Instrumentation validation
Analytical and laboratory certification
Documentation and maintenance of records
Consequences of noncompliance
Grounds for disqualification
Reinstatement of a disqualified facility
References
Who Should Attend:
Regulatory Affairs Departments
Quality Assurance Departments
Quality Control Departments
Research and Development Departments
Manufacturing Departments
Operations Departments
Production Departments
Documentation Departments
Validation Teams
Project Managers
Engineering Departments
Internal Auditing Personnel
Microbiology Personnel
Laboratory Personnel