QP Module: Mathematics & Statistics

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

Course outline

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

Statistical Techniques

• Data visualisation tools:
  • Histograms
  • 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?

Venue

Hilton York Hotel, York, UK

The Hilton York Hotel is conveniently located in the city centre and boasts 130 high-quality rooms, two popular restaurants and secure parking. The historic city of York has many attractions for visitors; the famous Minster, many museums, the Jorvik Viking Centre and excellent shopping. London is two hours away by train and there is a direct rail link to Manchester Airport. Leeds/Bradford Airport is also nearby.

Hotel Accommodation

• 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 will be provided to you on receipt of a completed booking form.
• 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.

Venue Address and Contact Details

Hilton York Hotel
1 Tower Street
York
YO1 9WD
England

Tel: +44 (0)1904 648 111

www.hilton.com

Hotel Bookings

If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following “this link - link to be confirmed shortly”

This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.

Tutors

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:

• David Young, University of Strathclyde, Glasgow, UK
• Bob Clarke

• 

  Mr Peter Gough
  Executive Director
  MSc, CSci, CChem, FRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999

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