Good Tissue Practices (cGTP) Quality Program
ATB Standards for Tissue Banking
Quality System Regulations (QSRs)
ISO 9001 & ISO 13485
Quality Documentation
Quality Manual (Policies)
Standard Operating Procedures
Forms
Quality Databases
Performance Metrics
Change Control System
Corrective and Preventive Action (CA/PA)
Documentation and Investigation of Deviations
Control of Nonconforming Materials and Product
Failure Investigation – Root Cause Analysis
Root Cause Analysis
Incomplete Problem Definition
Causal Relationships Unknown
Categorical Thinking
Training / Training Programs
cGMP, cGTP, and QSR Training
Establishing a Culture of Quality
Management Responsibility
Management Reviews
Corrective and Preventive Action (CA/PA)
Root Cause Analysis
Failure Investigation
Auditor Training
Total Quality Management (TQM)
Preparing for FDA Inspections
Adverse Reaction / Deviation Reporting
Management Training
Creating Goals
Measurement tools for tracking performance
Coaching for improved performance
Creating a quality culture
Developing a foundation for continuous improvement
Audit Management
Internal and Supplier Audits
GLP Audits
Non-clinical Laboratory Audits
Auditor Training
Gap Assessment
Validation Planning
Master Validation Planning
Validation Protocols (IQ/OQ/PQ)
Validation Reports
Validation Execution (available through associates)
483 & Warning Letters
FDA-483 and Warning Letter Resolution
Development of Corrective and Preventive Action Plans
Implementation
Communications / Meetings with FDA and/or AATB
Joint Commission Tissue Compliance
JCAHO Standards PC.17.10, PC.17.20, and PC.17.30
Liaison between Tissue Processors and Hospitals receiving
and storing Human Tissue products
Quality Culture Development
Management Behaviors in Fostering a Quality Culture
Awareness of quality, Leadership in quality, Encourage
self-development and empowerment, Provide opportunities
for employee participation