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Good Laboratory Practices (GLPS) Comparing and Contrasting With Good Manufacturing Practices (GMPS)

4461
Duration : 90 Minutes
Joy L. McElroy,

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more

Good Laboratory Practices (GLPs), CFR part 58 is 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. GLPs are not enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article 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.

Course Objectives:

We are often confused by differences between Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) as they relate to laboratory testing. This is understandable, since both GLPs and GMPs cover lab testing but are very different. The objective of this live webinar is to contrast between Good Laboratory Practices and Good Manufacturing practices.

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• 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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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