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Presenter: Joy McElroy

  • Date: 9/29/2022 11:00 AM - 9/29/2022 03:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


Nonclinical laboratory studies must comply with the Good Laboratory Practice (GLP) regulations prescribed in Title 21 CFR part 58. This has been crafted to ensure data quality and integrity. These studies 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. As per the FDA, GLP’s are meant for non-clinical laboratory studies in a controlled environment. This would involve test articles that are studied in test system under laboratory conditions with the primary objective to determine their safety and efficacy. This would not apply to studies utilizing human subjects, or clinical studies, or field trials on animals. GLPs are not enforceable by law; they do however protect scientific data integrity. They do not include the manufacturing of the product which is integral component of GMP. However, it is important to be able to compare and contrast GLPs with GMPs and understand their requirements. Join this virtual seminar, as our expert speaker Joy McElroy will compare and contrast between good laboratory practices (GLPs) and good manufacturing practices (GMPs). She will discuss the objective behind GLPs and how they associate with GMPs and SOPs, and the consequences of non-compliance.

Seminar Agenda:

  • Understanding good laboratory practices (GLP)
  • GLP as an FDA regulation
  • Definition of GLPs
  • History of GLPs
  • Why were GLPs created?
  • Objectives of GLPs
  • Mission of GLPs
  • 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
  • Grounds for disqualification
  • Reinstatement of a disqualified facility
  • References

Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments
  • Validation Teams
  • Project Managers
  • Engineering Departments
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Laboratory Personnel