Description
<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>
01/13/2009
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Medical Device
Course Category
Brochure Name
http://www.cfpa.com/PDF/2008/2179,C7-338,0711-718.pdf
Address
AN ON-DEMAND ONLINE TRAINING FORMAT On-Demand Training