Preparing for and Surviving an FDA Inspection Training Course :

This course provides a background and understanding of the role played by the Agency, it&rsquo;s administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections, i.e. pre-approval inspections (PAI), routine GMP inspections, bioresearch monitoring inspections, quality systems inspections techniques (QSIT) applied to device companies and system-based inspections program applied to drug companies. A detailed description of the six systems will be provided.<br><br> The course offers methodologies and techniques on:<ul><li> How a firm should prepare for an FDA inspection</li> <li>Ways to train employees in view of the inspection</li> <li>How to ensure that required documentation is in place</li> <li>How to interact with the investigator?DO&rsquo;s and DON&rsquo;T&rsquo;s</li> <li>What companies should do when the inspection ends</li> <li>How to reply to 483&rsquo;s and warning letters</li> <li>Legal implications of non-compliance</li> <li>Post inspection actions</li></ul> The course consists of lectures, discussions and a practical workshop which will enable participants to work in small groups and design a company policy/procedure for handling FDA inspections.<br><br> Attend this course and its companion course, <b>cGMP Auditing?Strategies for Compliance</b>, ID# 2012 (Offering # 0808-305) and save $300 off combined regular tuition.