All posts by k.stolarska

Watch webinar: Statistical process control according to Annex 15, how to get started?

Are you wondering what the basic principles of statistical process monitoring are? Do you want to start with statistical process monitoring and link it to OPV and PQR, but don’t know how to do it?

If your answer to at least one question is „YES” then fill in the form and join our webinar now!

In addition, during the webinar, we will explain:

  •  How to select quality characteristics for statistical process control
  •  What number of batches is sufficient to set control limits
  •  What if the points are outside the control limits
  •  How to assess the stability and capability of many parameters/processes
  •  What actions to take for processes that are not stable / not capable

In the second part, selected functionalities of the PQM Product Quality Monitoring program will be presented. This program is software designed for performing statistical analyses of data collected during product quality review and/or ongoing process verification.


Watch webinar: Statistical evaluation of compliance of results with specification limits

Do you want to know the rules regarding the compliance of the reported result with specification limits? Are you wondering about the role of measurement uncertainty in the decision-making process or how to use the results of analytical method validation and stability data in defining internal release limits?

If „yes” – don’t hesitate and join our webinar now!

In addition, during the webinar, we will be presented with examples of the:

  • calculating the probability of compliance with the reported value and the risk of making a wrong decision,
  • using the results of analytical method validation and stability testing in estimating internal release limits.

The second part of the webinar will present selected functionalities of the AMV Analytical Method Validation and PS Product Stability modules.


Watch webinar: The use of univariate and multivariate control charts in accordance with the recommendations of Ph.Eur. 5.28

Are you wondering what are the recommendations of European Pharmacopoeia Ph.Eur. 5.28 regarding to the implementation of statistical process control, which can be used during Ongoing Process Verification (OPV) or periodic Product Quality Review (PQR)?

Do you want to know the basic principles and procedure for implementing statistical process control using univariate and multivariate control charts?

If „yes” – I invite you to watch the webinar „Univariate and multivariate control charts as per recommendations of Ph.Eur. 5.28”.

We will show examples of the use of Shewhart’s univariate control charts and T2 Hotelling’s multivariate control charts. We will also present program for monitoring product quality ’StatSoft PQM’, along with its database extension.