cGMPs for Pharmaceutical laboratories: Current Regulations and Best Practices to Support Lifecycle Management
Kim Huynh-Ba / Anthony DeStefano
Length: 2 Day Course
Date: 3-6 / 3-7 – Sunday / Monday
Fee: $1050 ($1450 after 2/12/16)
Analytical chemists. QA/QC, R&D, project management, manufacturing, CROs, technical liaison, Regulatory scientists, inspectors, lab auditors, who work with generating, reviewing, evaluating analytical results of pharmaceutical products. You need at least 2-year experience in pharmaceutical industry to participate in discussion and get the full benefit.
Good Manufacturing Practices continue to be the regulations that safeguard the quality of medicines and the analytical laboratories provide the necessary control systems. Throughout this course, we will take a closer look at cGMP with an update of current guidances from FDA, ICH, USP, WHO, and how the laboratory controls can positively or negatively impact the company and the quality of the products it manufactures. This is a highly interactive course, where case studies through Warning Letters will be presented throughout the course. GMPs concepts will be reviewed and Best Practices for several quality systems supporting product lifecycle (i.e. analytical method, process change, documentation, training and equipment) can be discussed among participants. This course is not intended for microbiology laboratories.
Past Course Reviews
Great examples, very relevant topics
Good overview of impurities
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