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
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