Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites Training Course :

This course provides an <b>overview</b> of the FDA inspection process in general and of particulars applicable to &ldquo;foreign inspections&rdquo;. It provides a background and understanding of the role played by the Agency, its administrative and enforcement powers. The course provides a step by step description of the inspectional process with specific examples regarding cGMP compliance inspections and pre-approval inspections.<br><br> The latest FDA initiatives regarding inspections, like risk based approach and system based approach, will be discussed in detail. This will enable participants to better understand how to prepare their companies for FDA inspections.<br><br> The course consists of lectures, discussions, case studies analysis, and a hands-on workshop in setting up a company policy/procedure for handling inspections.<br><br> Attend this course and its companion course. <b>Auditing for cGMP Compliance</b>, ID#1881 (Offering # 0806-302) and save $400 off the combined tuition <b>(Note: Only combined regular tuition applies)