Knowledgeable, Trained and Experienced consultants are available to support your quality needs. Our consultants have a wide range of experience from over 20+ to 10+ years in the organ, eye, and tissue banking and biologics industries. We offer a range of fully customizable services that include
Quality Management
Regulatory and Compliance Management
Includes obtaining state, federal licensure, industry accreditation and ocular international submission
Contract Quality Management/ Quality Director
Change Control
Audits and Audit Responses
Validation Services
Process validation
Equipment validation
Tissue Chart Review
Project Management
Implementation of New Project
Short Term Projects
Large Scale Projects
AOPO Essential Standards Compliance Services
Risk Management
Business Continuity
Emergency Disaster Planning
Security and Data Risk
Training Development
Compliance Training
AATB, EBAA, UNOS, AOPO Standards Training
In-House Customized Quality Training
Quality Management Training,
Quality Tools (CA/PA, Root Cause Analysis, Risk Management, Six Sigma, Lean, etc..)
Competency Assessment Development and Best Practices
Value Added Process Improvement
GAP Analysis (Comparison of Actual Performance with Potential Performance)
Organ/UNOS compliance, process improvement and response support
Just cause audit prevention/preparedness
Program development of internal staff translation program
Consulting Projects Include
Start-Up company policy and QMS design, development, and implementation
Ongoing Contract Quality Management Oversight
Policy Development
Standard Operating Policy/Procedurey Manual Policy re-design
Customized Organization Training on Standards and Regulations
Internal Auditor Initial Training
Standards Overview Training
Tissue Chart Review
Quality Manager/Management Training
Integrating and Utilizing Quality Improvement Tools
Annual Management Review Support
Development and Design of Quality Metrics
Basic Validation Development and Executing