This is the first in a series of courses designed to instruct on current good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), as set out by the ICH Q7 Guideline. This online course covers the Introduction to ICH Q7 and Quality Management for API manufacture. The learner should have a working knowledge of current GMPs for drug products as set out in the Code of Federal Regulations, CFR 21 Parts 210 and 211, as well as a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients.
The International Conference on Harmonization (ICH) was created in 1990 with the primary aim of harmonizing the technical requirements for new drug product registration between the United States, the European Union, and Japan. It is supported by and involves regulators and pharmaceutical industry organizations from these three regions and from other countries including Canada and Switzerland. This course addresses the following:
Take Back to Your Job:
Attendance Suggested For: