Process Validation

Process Validation

I support organisations with the establishment, improvement and execution of Process Validation activities in regulated life science environments.
My experience covers Medical Devices, IVD and Pharmaceutical Primary Packaging and includes both internal and outsourced manufacturing processes.

Areas of Support

I can support organisations with:

  • Validation strategy and planning
  • Process Validation procedures
  • Validation plans, protocols and reports
  • Qualification activities, including DQ, IQ, OQ and PQ where applicable
  • Risk-based validation approaches
  • Review and improvement of existing validation processes
  • Training and knowledge transfer

Process Validation Experience

As a consultant, I have supported both small and large organisations in establishing and improving their Process Validation approach and in preparing and executing the required validation documentation.
I have also worked with validation of subcontracted processes and with defining appropriate controls and responsibilities between manufacturers and external suppliers.

Risk-Based Approach

Process Validation should be based on an understanding of the process and its associated risks.
I use risk-based approaches to ensure that validation activities and documentation are proportionate to the process risk and intended use.

Regulatory and Quality Frameworks

My experience includes Process Validation in accordance with ISO 13485, ISO 15378 and other applicable regulatory and quality requirements.

If you would like support with a Process Validation activity or the development or improvement of your validation approach, you are welcome to contact me.