Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

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

Instructor Profile:

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.