Conducting Compliant Endotoxin Testing Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>The essential elements of the bacterial endotoxins test are addressed in this 11/2 hour course. Proper and appropriate inclusion of these elements in an LAL testing program will result in compliant testing. Performance of properly understood endotoxins tests benefits any company releasing products with endotoxin specifications and may avoid significant compliance problems.<br><br> <b>Module 1: General Principles and Introduction</b> <li>The five essentials of endotoxin testing</li> <li>The USP, EP and JP Harmonized Endotoxins Test Chapters</li> <li>Prerequisites for endotoxins tests:</li> <li>Apparatus and Glassware</li> <li>Standard Endotoxin stock solution and dilutions</li> <li>Preparatory Testing</li><br> <li>Endotoxin Limits</li> <li>Maximum Valid Dilution (MVD)</li></ul><br><br> <b>Module 2: USP Bacterial Endotoxins Test Requirements for Gel-clot and Photometric Techniques</b> <li>Photometric Techniques</li> <li>The Gel-clot method</li> <li>Preparatory Testing</li> <li>Gel-clot Limit Test</li> <li>The Gel-clot Assay</li> <li>Photometric Techniques</li> <li>Preparatory Testing</li> <li>Gel-clot Limit Test</li> <li>Test Procedure</li> <br></li><br><br> <b>Module 3: Compliant LAL Tests and the FDA Guideline</b> <li>Technician and Laboratory Qualification</li> <li>Control Standard Endotoxin (CSE)</li> <li>CSE potency determination</li> <li>The USP position on CSEs</li> <li>Certificates of Analysis (Potency)</li> <li>When to repeat validation</li> <li>Pooling Samples for Testing</li> <li>Out of Specification Results and Repeat Testing</li>