The objective of this seminar is to compare and contrast Good Laboratory Practices and Good Manufacturing Practices.
GLPs are enforceable by law. They do not include the manufacturing of products. GLPS are for non-clinical laboratory studies in which tests article are studied in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, clinical studies, or field trials on animals.
Why you should attend
Good Laboratory Practices (GLPs), 21 CFR part 58 are not a set of guidelines but they are regulations 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.GLPs are enforceable by law. They do not include the manufacturing of products. GLPS are for non-clinical laboratory studies in which tests article are studied in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, clinical studies, or field trials on animals.
Learning Objectives:
- What are Good Laboratory Practices
- Why were they created?
- What is 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 non-compliance
- Disqualification and reinstatement
Agenda
- GLP: Good Laboratory Practice
- GLP is an FDA Regulation
- Definition of GLPs
- History of GLPs
- Why was GLP Created?
- Objectives of GLP
- Mission of GLP
- Instrumentation Validation
- Analyst Certification
- Laboratory Certification
- Grounds for Disqualification
- Consequences of Noncompliance
- Reinstatement of a Disqualified Facility
- References
Speaker
Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab.
Who Should Attend
- Quality Assurance Personnel
- Quality Control Personnel
- Research and Development Personnel
- Regulatory Affairs Personnel
- Project Managers
- Manufacturing Managers
- Validation Engineers
- Internal Auditing Personnel
- Microbiology Personnel
- Auditors
