Good Laboratory Practices (GLPs), 21 CFR part 58 is a set of guidelines 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 not 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.
GMPs, Good Manufacturing Practices, 21 CFR part 210 and 211, is a set of guidelines for the actual manufacturing and packaging of finished products. The GMPs are enforceable by law. During this course GLPs and GMPs will be compared and contrasted. The differences and similarities will be discussed. The attendees will gain a better understanding of how these guidelines work together and enable the finial production of quality products.
During this webinar participants will learn what GLPs and GMP are, how they are similar and how they are different. They will learn how and why both these regulations were created, a brief history of each will be given.
Participants will have a better understanding of the importance of these regulations and how they work together to enable production of the highest quality products.
Participants will also gain an understanding of the consequences of noncompliance such as disqualification and reinstatement.
• Medical Devices
• Medical Devices
• Contract Laboratories
• FDA inspection methodology
• Personnel qualification and training
• Standard Operating Procedures
• Analytical Methods
• Raw data (notebooks, print-outs)
• Document management (change control, retention)
• Part 11 (electronic records and signatures)
• Sample collection
• Sample delivery, handling, disposition
• Retain samples
• Organization and management
• Storage units
• Analytical methodology
• Reagents, chemicals
• Out-of-specification results
• Root cause analysis
Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.
What You Get:
Joy L. McElroy,
Upon earning a degree in Zoology at North Carolina State University, Joy 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 14 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, 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.
In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.