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4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) Comparing and Contrasting GMP - Webinar

  • ID: 4833612
  • Webinar
  • February 2021
  • Region: Global
  • 4 Hours
  • NetZealous LLC
UP TO OFF
until Nov 30th 2021
Overview:

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Why you should attend:

Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations 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 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
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Session 1
  • GLP: Good Laboratory Practice
  • GLP is an FDA Regulation
  • Definition of GLPs
Session 2
  • History of GLPs
  • Why was GLP Created?
  • Objectives of GLP
Session 3
  • Mission of GLP
  • Instrumentation Validation
  • Analyst Certification
  • Laboratory Certification
Session 4
  • Grounds for Disqualification
  • Consequences of Noncompliance
  • Reinstatement of a Disqualified Facility
  • References
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Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab.

In 1998 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
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  • 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
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