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 p>

Complaint File
The Human Tissue cGTP Regulation in a Nutshell







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






 
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