4-Hour Virtual Seminar

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

Product Id : 10296
Joy McElroy

Price Details

$445.00 Live
$645.00 Corporate Live
$495.00 Recorded
$845.00 Corporate Recorded
Combo Offers
Live + Recorded
$752.00   $940.   (20% Off)
Corporate (Live + Recorded)
$1,192.00   $1490.   (20% Off)

Refund Policy

Price Details  +

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

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

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

Speaker Profile
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.

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.

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