Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Duration: 90 Minutes
Attend the webinar to get a proper contrast and comparison of GMP and Good Laboratory Practices (GLPs), CFR part 58, for conducting nonclinical laboratory studies that 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 and GMPs
Instructor: Joy L McElroy
Product ID: 501833
Objectives of the Presentation
Upon completion of this program you will know:
  • 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
Why Should you Attend
Periodically one hears the comment that 'a laboratory or a manufacturing facility meets 21 CFR Part 58 and therefore they meet the entire cGMP requirements.' Contrary to popular belief, 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and do not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not 'watered down' GMPs.

Good Manufacturing Practice (cGMPs) represents that part of Quality Assurance that ensures the products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification. Non-Clinical laboratory studies (58.1) support or are intended to support application for research of marketing permits for the following products to include:
  • Food and color additives
  • Human and animal drugs
  • Medical devices for human use
  • Biological Products
  • Electronic Products
GLPs do not include manufacturing product. Non -clinical Laboratory Studies (58.3) include in vitro or in vivo experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. This does not include studies utilizing human subjects or clinical studies or field trials in animals.

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

Areas Covered
  • GLP: Good Laboratory Practice
  • GLP is an FDA Regulation
  • Definition of GLPs
  • History of GLPs
  • Why was GLP Created?
  • Objectives of GLP
  • Mission of GLP
  • Instrumentation Validation
  • Analyst Certification
  • Laboratory Certification
  • Grounds for Disqualification
  • Consequences of Noncompliance
  • Reinstatement of a Disqualified Facility
  • References
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
$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
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.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

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

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off site training to pharmaceutical and biotech companies throughout the United States, Canada, and the world.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
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