Pharmaceutical cGMP-Quality Systems Training Course :

<strong>Course Schedule - January 8, 2009 at 11:00 a.m. - 12:30 p.m. (EST)</strong><br/><br/>This 90-minute <b><i>accredited</b></i> online training course will focus on the elements, responsibilities and measurements of the pharmaceutical Quality System, the primary system of FDA's Systems Based Inspection Program. Special attention will be paid to components of the system that are often problematic and focused on by regulators. Identification of common tools that can be used by pharmaceutical personnel to solve problems and the elimination of manufacturing non-compliance will be discussed.<br><br> <b><u>Module 1:</b></u><br>   • Key elements in a Quality System<br>   • What are the key Quality Systems?<br>   • Who is responsible for these Systems?<br>   • What are metrics?<br><br> <b><u>Module 2:</b></u><br>   • Change Control<br>   • CAPA - Investigation - Corrective Actions<br>   • Validation<br>   • Audit<br>   • Training<br>   • Calibration<br><br> <b><u>Module 3:</b></u><br>   • Easy ways to see if the system is broken<br>   • Simple remedies<br>   • The pharmaceutical workers' role in maintaining the<br>      integrity of Quality Systems<br><br> <b>Question and Answer Session</b>