cGTP in a Nutshell Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>The release of the Current Tissue Practice Regulation in 2005 represented a watershed change for the Human Tissue Industry and for other FDA regulated industries where human tissue is used as a component. This course is intended to provide training in the nuts and bolts of this landmark regulation.<br><br> <b>Module 1:</b><ul><li> Introduction: The Big Picture: 21 CFR Part 1271, Subparts A through E</li> <li>Subpart D, the sixteen subsections of the cGTPs</li> <li>The Core Requirements</li> <li>Comparison with the cGMPs (pharma) and the QSRs (medical devices)</ul></li><br> <b>Module 2:</b><ul><li> What is a Quality Assurance Program? What does it do?</li> <li>What are the Personnel requirements? Procedure requirements?</li> <li>What about my Facility? Environmental Controls?</li> <li>Equipment: what are my requirements?</li> <li>Processing and Processing Controls</li> <li>Controls for Supplies and Reagents</li> <li>Recovery Controls</ul></li><br> <b>Module 3:</b><ul><li> Processing and Processing Controls. What about Process Changes?</li> <li>Labeling Controls</li> <li>Storage Controls</li> <li>Receipt, Pre-distribution Shipment and Distribution requirements</li> <li>Control of Records</li> <li>Tracking requirements</li> <li>Complaint File</ul></li>