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.