What is FDAs risk-based approach to CGMP?
• What is PAT? • Can STAT-A-MATRIX help with interpreting all of these changes and developing programs to address them? • Does STAT-A-MATRIX work with start-up companies as well as established organizations in the pharmaceutical industry? • Is compliance with the FDA regulations the same as conforming to ICH guidelines or ISO standards? • What are some other areas where STAT-A-MATRIX can help? • What training programs does STAT-A-MATRIX offer that may be appropriate to my needs? The Food and Drug Administration (FDA) regulates foods, drugs, medical devices, biologics, animal feed and drugs, cosmetics, radiation-emitting products, and combination products. The mission of the FDA is: • “To promote and protect the public health by helping safe and effective products reach the market in a timely way, • To monitor products for continued safety after they are in use, and • To help the public get the accurate, science-based information needed to improve health.” What divisions of FDA regulate
