|
Download Brochure
|
Course offering number:0711-718
Course ID:
2179
cGTP in a Nutshell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training 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
Description
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.
Module 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)
Module 2:-
What is a Quality Assurance Program? What does it do?
- What are the Personnel requirements? Procedure requirements?
- What about my Facility? Environmental Controls?
- Equipment: what are my requirements?
- Processing and Processing Controls
- Controls for Supplies and Reagents
- Recovery Controls
Module 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