There is a growing need in the pharmaceutical industry to develop fast and reliable analytical procedures and strategies within a short timeframe. This course details the role of the laboratory analyst in the pharmaceutical industry. Topics include: the CFR and ICH regulations and guidelines in relation to the pharmaceutical industry; the US Pharmacopoeia and other compendial methods; and analytical method development (e.g. HPLC and LC/MS). Additionally, how these methods are used for raw material analysis, drug substance, drug product, stability studies and bioavailability studies will be explained.
Course Number: BIOL-40195
Credit: 3.00 unit(s)
Related Certificate Programs: Advanced Studies in Regulatory Science