Service and Support

An integral part of your team I can provide support in all aspects of your sterilisation process, such as:

Service – Support

  • New Process Specification, URS generation
  • Process Development and Equipment Qualification: Moist Heat, Dry Heat, VHP
  • Process Optimisation and Cycle Development
  • Independent approval of annual and periodic test reports
  • Factory Acceptance Testing oversight
  • Coaching - Mentoring
  • Sterilisation equipment and process Gemba
  • Group coaching
  • Individual skills and knowledge development

Quality – Regulatory – Standards

  • BS / EN / ISO Technical Support
  • Gap Assessment
  • Technical Writing and Support to cGMP and Regulatory requirements
  • Policy, Procedure and Work Instruction - development and support.
  • Validation documentation - generation and approval
  • Auditing
  • Internal sterilisation audits for compliance to internal policy and procedures
  • Manufacturing and sterilisation supplier technical audits.
  • Technical Support

Contact

For further information about me or my service, please get in touch using one of the contact details below. Or fill in the form and I'll get back to you asap.