QP Module 6: Mathematics & StatisticsPrint
The Pharmaceutical Industry and the Regulatory Authorities are becoming increasingly aware of the benefits that statistical techniques can provide
£2560.00 excl. VAT – £3072.00 incl. VAT
About this course
The introduction of the EU requirement for Product Quality Reviews, ICH Q8, Q9, Q10 and Q11, and new guidance from both the FDA and EU on Process Validation, which includes ‘continued process verification’, all mean that the Pharmaceutical Industry and the Regulatory Authorities are becoming increasingly aware of the benefits that statistical techniques can provide and the vital information that can be obtained by trend analysis. This module assumes that delegates have little or no experience in the application of statistical techniques and will demonstrate how simple statistical tools can be used to turn data into useful information.
The provision of useful information is essential to the Qualified Person and other professionals in helping them to:
- Understand the reliability and accuracy of data and information arising from samples taken from a population
- Monitor and detect adverse trends before a process goes out of control
- Assess the capability and reliability of a process
- Understand the interaction of process parameters via experimental design
- Maintain regulatory compliance
Basic Statistical Quantities
- Terminology and definitions
- Measures and visual plots to describe populations and samples
- Deciding how much data to collect to enable appropriate decision making to occur
- Data visualisation tools:
- Box plots
- Confidence intervals
- Statistical Process Control (SPC) tools:
- Shewhart and Cusum control charts
- Pareto charts
- Fishbone diagrams
- Process capability (Cp and CpK)
- ISO 2859 – Specification for sampling procedures and tables, application of sampling by attributes
- Regression analysis
- Statistical testing:
- The t-test
- Analysis of Variate (ANOVA)
- Outlier testing
- Experimental design, eg Taguchi
- Multi-variate analysis
Practical Application of Statistical Techniques
- Practical examples of the application of statistical techniques using teamwork sessions
- Experience of the application of statistical techniques in a QA system within a manufacturing environment
- The role of computers in the application of statistical techniques
- Six Sigma: What is it and what are its benefits?
York Marriott Hotel, York, UK
The York Marriott Hotel is within walking distance of York city centre and its many attractions. With 151 stylish guest bedrooms the hotel is ideal for the business or social traveller.
Secure WIFI internet access is available in public areas and their recently refurbished Leisure Club features a heated pool, sauna, steam room, jacuzzi, gymnasium and private tennis court.
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
- Professor George Gettinby, Department of Statistics and Modelling Science, University of Strathclyde, Glasgow, UK
- Plus invited guest speakers
What you've said
“Really good, excellent balance of lectures and practical.”
Kate Smith, Penn Pharmaceutical Services, UK
“Really enjoyed the course and amount of workshops/problems made applying the lecture material to real life problems seem easy!”
David Franks, Reckitt Benckiser Healthcare, UK
“Tutors did a great job of explaining basic concepts so we could apply them to more complex problems/concepts. I feel like I have learned how to use many tools to turn data into information so I can go back and learn more about our process control and capability.”
Laura Matthys, Reckitt Benckiser Healthcare, UK
“Wonderfully well organised course with just the right balance between lectured theory and practical application in team work exercises.”
Nuno Furtado, Baxter Healthcare, UK
“The use of practical examples suggested lots of improvements to take back to base!”
Kasia Averall, Genzyme, UK
“The course has given me the confidence and knowledge to make some real improvements at my site!”
Beth Halliday, Penn Pharmaceutical Services, UK