4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) vs GMPs – Comparison and Contrasts

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

Course Director: 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. 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 and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence. Her knowledge, experience, 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, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance. 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. 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.