Description
This GLP professional certification program is designed to train and certify workers responsible for maintaining quality in a regulated lab.
Students completing this professional certification will be able to explain the principles of current good laboratory practices (cGLP), its importance within a regulated laboratory environment, the benefits of GLP, and how it leads to the creation of technically defendable scientific data, by which the labs quality, reliability, and trustworthiness can be assured.
This program introduces Good Practices (GxP) in drug development and manufacturing, and dives deep into the good laboratory practice guidance for non-clinical laboratories. Then, the program moves on to discuss good quality control laboratory practice (G(QC)LP). Stability testing programs, sampling plans, and validation are also described in detail. An introduction to pharmacokinetics and pharmacodynamics in drug development and registration is provided, before moving on to learning how to conduct pharmacokinetic and pharmacodynamic studies. This program also includes sections on good documentation practices (GDocP), describing how documentation must be done, and how records must be kept. A section on data integrity is also provided to assure students understand these requirements. Details on quality assurance and quality control (QA/QC), with respect to good manufacturing practices, are provided. Participants will explore GMPs as they apply to quality testing, management, manufacturing, and the control of pharmaceutical products. The course moves on to describe how to implement corrective and preventive action (CAPA) in detail, including a description of how to conduct a root cause analysis.
