Are you data rich but information poor? Our pharmaceutical statistics training course provides you with the essential understanding of several fundamental statistical process control (SPC) tools for analyzing data. This training will enable you to understand what the output from these tools is telling you about your product or process. This, in turn, will give you powerful information that you can use to provide continuous trending and to drive quality improvement.
The pharmaceutical industry has historically underutilized SPC techniques that have been used extensively in many other industries to drive product and process improvement. Even today, the pharmaceutical industry could still be characterized as being data rich but information poor.
Current EU and U.S. GMP process validation guidance (such as EU GMP Annex 15, ICH Q10 and U.S. guidance on process validation) emphasizes the need for ongoing/continued process verification by the trending of data. The well-established SPC techniques are perfect for meeting this expectation.
Performing the necessary statistical calculations is now relatively simple with a variety of software packages available to do the number crunching. However, to obtain the maximum benefit from the use of these sophisticated statistical software tools, it is vital that the outputs are correctly interpreted.
This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development (CPD).
On completion of this course, delegates will know and understand:
Course tutors will be selected from the following:
Peter Gough - Peter is an analytical chemist with over 40 years’ industry experience in applying statistical techniques to pharmaceutical manufacturing, testing and quality management.
Richard Kettlewell - Richard has a master’s degree in pharmaceutical sciences and has over 30 years’ industry experience in a number of QC, QA and technical roles.
David Young – David is a senior lecturer in the Department of Statistics and Modelling Science, University of Strathclyde who has carried out statistical consultancy work for the NHS, pharmaceutical companies and Health Protection Scotland.