Process Validation in a Nutshell Training Course :

Process Validation has 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 planning and preparing for process validation, and includes a discussion of how to write validation protocols, handle deviations, report validation results and &ldquo;maintain the validated state.&rdquo; Further, this course provides &ldquo;content understanding&rdquo; so important for auditing validation activities as required in today's FDA regulated industry environment.<br><br> <b>Module 1:</b><br> <li>Background-Regulatory Requirements</li> <li>Why do I need to validate processes?</li> <li>What is process validation?</li> <li>Does every process need to be validated?</li> <li>So when do I need to validate a process?</li><br><br> <b>Module 2:</b><br> <li>Validation Planning: The Validation Master Plan</li> <li>Validation Basics</li> <li>IQ, OQ, PQ: what are all these letters in the alphabet soup?</li> <li>Validation Protocol Basics and Content</li><br><br> <b>Module 3:</b><br> <li>Handling Deviations</li> <li>Validation Reports</li> <li>When do I need to do all this?</li> <li>How do I &ldquo;maintain the validated state,&rdquo; and what does that mean, anyway?</li>