The Human Tissue cGTP Regulation in a Nutshell

Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included

Who Will Benefit

This training solution will benefit professionals in the following industries:
Human Tissue Processors, and Medical Device manufacturers where human tissue is used as a component.

In departments such as:
QA/QC/RA, Manufacturing/Operations, Research and Development, Distribution, Legal

With job functions:
Department managers and supervisors, QA/QC/RA specialists and engineers, Manufacturing and R&D engineers, chemists, scientists, formulators, documentation specialists, auditors, technicians

Course Description
The release of the Current Good Tissue Practice Regulation (cGTP) 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.

  • Section 1:
    • Introduction: The Big Picture: 21 CFR Part 1271, Subparts A through E
    • Subpart D, the sixteen subsections of the cGTPs
    • The Core Requirements
    • Comparison with the cGMPs (pharma) and the QSRs (medical devices)
  • Section 2:
    • What is a Quality Assurance Program? What does it do?
    • What are the Personnel requirements? Procedure requirements?
    • What about my Facility? Equipment? Environmental Controls?
    • Processing and Processing Controls
    • Controls for Supplies and Reagents
    • Recovery Controls
  • Section 3:
    • Processing and Processing Controls. What about Process Changes?
    • Labeling Controls
    • Storage Controls
    • Receipt, Pre-distribution Shipment and Distribution requirements
    • Control of Records
    • Tracking requirements
    • Complaint File
    • The Human Tissue cGTP Regulation in a Nutshell

Order On-Line to Own This CD Webinar: $195.00