Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Instructor:
Joy McElroy
Product ID: 704086
- Duration: 120 Min
Why Should You Attend:
Good Laboratory Practices (GLPs), CFR part 58, 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.
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.
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 noncompliance
- Disqualification and reinstatement
Areas Covered in the Webinar:
- GLP: Good Laboratory Practice
- GLP is an FDA Regulation Training
- 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
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
Joy McElroy
Principle Consultant, Maynard Consulting Company
Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
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