ICH Q7A: Introduction and Quality Management

Recognize the purpose of the Q7 Guideline and how it fits in with current regulatory expectations and practices in the United States — especially in the context of the FDA’s systems-based inspections program, 7356.002F. Recognize the basic terminology and applications of Q7 and the principles of an effective quality management system for Active Pharmaceutical Ingredients (API) manufacture.

After this course learners will be able to identify how to get help when you are unsure of the best course of action.