Complaint Systems - The Essential Requirements Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>Complaint Systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry/FDA environment and will give you tools for survival; it will provide a step-by-step guide to the essential requirements of a Complaint System including setting-up, operating, and managing the system for today’s FDA regulated industry environment. Further, this course provides “content understanding” so important when auditing Complaint Systems. <br><br> <b>Module 1:</b><ul><li> Background-Regulatory Requirements</li> <li>Key Definitions: what is a complaint, anyway?</li> <li>What needs to be in my complaint procedure?</li></ul> <b>Module 2:</b><ul><li> Complaint Receipt</li> <li>Complaint Review: Is it an MDR?</li> <li>Complaint Investigations; so, why did it fail anyway?</li></ul> <b>Module 3:</b><ul><li> Do I need to take Corrective Action?</li> <li>Can I close this complaint already?</li> <li>What is Complaint Trending and why do I need to do it?</li> <li>Resources, Record-keeping, and other Essentials</li></ul>