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
  • Change Control
  • 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

 

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Training Development

  • Compliance Training
  • AATB, EBAA, UNOS, AOPO Standards Training

 

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/preparedess 
  • 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
 

Contact Us for More Information!

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