The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices training.
Why Should You Attend:
Good Laboratory Practices training (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.
Areas Covered in this 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
Grounds for Disqualification
Consequences of Noncompliance
Reinstatement of a Disqualified Facility
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
Analytical and laboratory certification
Documentation and maintenance of records
Consequences of noncompliance
Disqualification and reinstatement
Who Will Benefit:
Quality Assurance Personnel
Quality Control Personnel
Research and Development Personnel
Regulatory Affairs Personnel
Internal Auditing Personnel
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.
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