Process Characterization and Validation

We ensure that all required PC and PV elements and their interdependencies are addressed, we establish an efficient, transparent and cost-effective plan for PC and PV stages and we provide technical expertise to your internal team

Guaranteed transparent and cost-effective execution of PC and PV stages

What we do

  • Set-up and advice on process characterization and validation studies
  • Schedule process characterization and validation studies
  • Manage process characterization and validation studies
  • Manage documentation processes
  • Reveal interdependent project stages and provide practical solutions for project clashes
  • Review and write PC and PV documents
  • Perform project risk management

What we deliver

  • PC and PV milestones in time
  • Gap analyses
  • Regular project risk assessments
  • Clearly written and well structured documents such as
    • PC Master Plan,
    • Validation Master Plan 
    • Validation Protocols
    • Validation Master Report

Well organised PC and PV projects with insight in all interdependable tasks

My experience

Successfully managed process characterization and validation project from first risk assessment to regulatory submission
Managed ad interim process characterization and validation project
Consulting for process characterization and validation project 

My work

A case on how an existing risk assessment was adapted so it could be used in a process characterization study to identify potentially critical process parameters.

Download the case here

 

Read more about my work here  

Contact

Do you need help with process characterization and validation?

 

Contact me...