Statistical Techniques to Support QbD and Process Validation Programmes

  • May 16, 2017
    9:00 am - 4:30 pm


4646 Dufferin St, North York, Ontario, Canada, M3H 5S4

Certification Areas

Event Objective

Participants in this course will be introduced to statistical tools which can be used to enhance the level of process and product knowledge and scientifically support many aspects of the process validation lifecycle, as described in regulatory guidance documents.

Event Description

In January 2011, the FDA published the guidance:  Process Validation:  General Principles and Practices; which described the recommended lifecycle approach in three stages:  Process Design, Process Qualification and Continued Process Verification.  This one day course will provide an overview of a variety of statistical tools which can be applied during each stage to help ensure that it is “planned and conducted according to sound scientific principles”.  Topics such as: sample size, confidence intervals, process capability (Cp/Cpk), hypothesis tests and control charts will be discussed using a variety of pharmaceutical based examples and classroom exercises to demonstrate real life applications.  In addition, more advanced tools such as DoE, Monte Carlo simulation and tolerance allocation, will be introduced conceptually, to provide a general understanding of the fundamental principles behind these tools.  This will illustrate their utility for enhancing process knowledge and conducting product investigations.

Who should attend?

The three stages of process validation span the complete product life cycle, and as such, it crosses a broad range of functions found within a pharmaceutical organization. This course will be beneficial for anyone who wishes to increase, or refresh, their understanding of basic statistical tools and obtain an introduction to the general principles of more advanced statistical tools. In particular, it would be of interest to professionals in the areas of pharmaceutical development, process validation, technical support, and quality assurance, as well as those involved in the preparation and interpretation of regulatory documents.