Is there a GLP certification?
For the GLP certification, you must take three core courses on good laboratory practices, writing process documents and clinical trial project management and one elective with varying topics.
What is a GLP certificate?
This course provides training on good laboratory practice for non-clinical laboratory studies that reflects regulations and best practices established by key regulatory agencies and guidelines.
Who certifies GLP?
CfPIE provides GLP Facility Certification for the: Pharmaceutical industry. Medical Devices industry.
Does FDA require GLP?
A10: Yes, as discussed in question 3, the GLP regulations govern nonclinical laboratory studies conducted in support of FDA research and marketing applications for medical devices, regardless of where the testing is conducted.
Is GLP and GMP the same?
“GMP” is Good Manufacturing Practices, and “GLP” is Good Laboratory Practices. Both the GMP and the GLP are regulations that are governed by the Food and Drug Administration (FDA). These regulations are imposed for ensuring the safety and integrity of drugs.
What are the GLP requirements?
GLP work requires at minimum 2 or 3 individuals. These are the person performing the work (analyst), a person reviewing the work (management), and a quality assurance reviewer (QA). If SOPs are written well, the analyst and the management can be the same individual; however, QA must always be an independent person.
What is GLP compliance auditing?
GLP Compliance Auditing. Any non-clinical laboratory facility you use to conduct safety and toxicology testing in animals may be subject to inspection by FDA, EPA, or other regulatory bodies.
Who should take a GLP course?
Target Audience: Anyone needing to learn about GLP regulations, including, but not limited to: QA Personnel (GLP Auditors), Study Directors, Principal Investigators, Management, Scientists, Technicians, Facilities Personnel, and Archivists, with 0-2 years or more of experience. This is a basic course.
What is the purpose of the FDA GLP course?
Description: This course intends to equip the participant with a working knowledge of GLP impacts on study conduct through a thorough examination of the basics of the history of the FDA GLPs and the regulations. There are periodic comparisons with EPA GLPs as well.
What happens if a study director does not ensure GLP compliance?
If a Study Director does not have the ability to ensure both GLP compliance and data integrity, they can be subject to a Form 483, other Warning Letters, and more.