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Global Compliance Panel presents

Virtual Classroom (Live) Good Laboratory Practices (GLPs) Comparing and Contrasting GMP Webinar

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

Course Description/Agenda


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.


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

Agenda

  • 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

Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She 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 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. 

With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. 

Upon earning a degree in Zoology at North Carolina State University, She 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 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. With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

 

More Webinar Information

Global Compliance Panel
Global Compliance Seminars

Course Summary

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

Delivery Method

Virtual Classroom (Live) Virtual Classroom (Live)

Who Should Attend

• 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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