Regulatory Requirements training

Effective Continued Process Verification (CPV)
R103 - 2 days

Continued process verification (CPV), which is a requirement of all regulatory agencies and the World Health Organisation (WHO), is the collection and analysis of production data to ensure product outputs are within predetermined quality limits.  The analysis involves using statistical process control (SPC) techniques to evaluate process stability and capability.  Regulatory agencies recommend that a statistician or person with adequate training in SPC techniques carry out these evaluations, which, if properly carried out, can identify variability in the process and/or signal potential process improvements.  This two-day training course will provide the necessary training for anybody wanting to undertake CPV.

Topics covered

  • Introduction - external and internal drivers, effective vs. ineffective CPV, and a proposed CPV workflow
  • Process Stability - develop an awareness of process stability by understanding the different types of variation that are present in a process and using this understanding to select an appropriate improvement strategy
  • Statistical Control Charts - history of control charts, types of control charts, short-term vs. long-term variation, rules for detecting special cause variation, common pitfalls, and practise creating, updating and interpreting control charts
  • Process Capability - voice of the process vs. voice of the customer, process capability ratios, alternative process capability metrics, common pitfalls and practise evaluating process capability
  • Measurement Systems Analysis (MSA) - importance of capable measurement systems, accuracy and precision, MSA vs. Gauge R&R studies, goals of a MSA study, crossed and nested MSA studies, practise analysing MSA studies

Software Tools Used

We regularly run this course using the following software packages, but please just contact us if you'd like to discuss using your current in-house tool instead:

Who should attend?

  • Individuals who are responsible for performing CPV analysis, and those who need to interpret the resulting control charts and capability metrics

Recommended Preparation

Familiarisation with FDA (CDER, CBER and CVM), Process Validation: General Principles and Practices, guidance for industry, January 2011. p 14 (Section D. Stage 3 – Continued Process Verification)

Note: Whilst not a necessity, given the nature of this course, we’d strongly recommend clients provide their own data for inclusion, allowing attendees to explore how CPV can be implemented in their own specific working environments. Preparation time may therefore be required, in order to customise the workshop. 

 

There are no public workshops currently scheduled for this course - please contact us to learn when we'll next be running it, or if you'd like to discuss an on-site delivery.