Q10 Pharmaceutical Quality System

This course describes a model for an effective quality management system for the pharmaceutical industry. The course is based on guidance developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is supported by the Food and Drug Administration (FDA) and is representative of their current thinking on this topic. Topics in this course include: Enablers, Management, Product Lifecycle, Process Performance, CAPA and Change, and Management Review and Improvement. After completing this course, learners will be able to recognize the approach to take in ensuring the pharmaceutical Quality System has the important principles needed to meet regulatory guidance.References:FDA Guidance for Industry “Q10 Pharmaceutical Quality System,” ICH, April, 2009. 21 CFR Parts 210, 211, 600, and 606.Guidance for Industry, “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations,” FDA, September 2006.Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections, Program 7356.002, FDA, September 11, 2015.“Quality Systems for Drugs and Biologics,” Pharmaceutical Technology, February 2, 2008.

After this course learners will be able to identify the approach to take in ensuring the pharmaceutical quality system has the important principles needed to meet regulatory guidance.