Gerry O'Dell Consulting
Sterilization and Microbiology Consulting

Sterilization and Microbiology Consulting for the Medical Device, Biologics and Pharmaceutical Industries

Capabilities


 

Gerry O’Dell can provide technical advice, compliance audits, validation design and execution, or training to your organization for processes related to sterilization, testing, and general microbiological quality.  The following areas of support are available: 

  •         Sterilization validation development and execution
  •         Sterilization process optimization
  •         Sterilization cycle design
  •         Sterilization program management
  •         Environmental control programs
  •         Validation development and execution for laboratory processes or equipment
  •         Internal Audits
  •         Supplier Audits
  •         Investigations into
    • OOS conditions
    • Sterilization process failures
    • Validation nonconformities
  •         Documentation review and preparation
  •     Sterilization/Microbiological Training

 

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