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

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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

 

Contact Us for More Information!

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