ICH-Q7 Training Course :

<strong>Course Schedule - June 1-3, 2009</strong><br/><br/>This course will prepare you to meet the varied challenges now facing the global active pharmaceutical ingredient industry. It is important that API production facilities operating under different national and international regulatory authorities not be required to meet diverse standards. For this reason an Expert Working Group in ICH developed the ICH-Q7 document as a single standard that all suppliers must apply to production of APIs used in human drug products manufactured in any of the ICH signatory regions.<br><br> This course will provide historical insight into the development of the Q7 document and specific interpretation of requirements in the document. The Q7 document addresses all aspects of API production in 19 sections. Each of these sections will be examined in detail during the course. Throughout the formal presentations participation by the registrants is welcome.<br><br> There are interactive exercises periodically spaced through the first two days that allow registrants to analyze real life situations that occur in typical operations. These afford an opportunity to exchange information and approaches with colleagues. The final activity is a workshop in which registrants are asked to apply what they have learned to resolve issues in test cases.