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Course summary
4 days
Full time
Online courses

Course description

Mathematics and Statistics

There are many training courses on statistics and statistical analysis, but very few which focus specifically on the application of these techniques to pharmaceutical manufacture and control. This is one such course! Designed to meet the needs of the aspiring Qualified Person and other pharmaceutical professionals and taught by a combination of statisticians and pharmaceutical industry professionals, this highly participative four-day mathematics and statistics pharmaceutical training course will teach you how to use statistical techniques to assess and monitor the reliability and accuracy of data you generate and the capability and reliability of the processes you work with. A pharmaceutical statistics course like no other!

The pharmaceutical industry has historically underutilized statistical data analysis techniques that have been used extensively in many other industries to drive product and process improvement. It is still too often true to characterize the pharmaceutical industry as being data rich but information poor.

Recent developments in the GMP Guidelines that provide regulatory expectations around the globe are now seeking to drive pharmaceuticals to catch up with other industries by placing far greater emphasis on the trending of data; e.g. EU and US requirements for ongoing process verification as part of process validation, in Product Quality Reviews and ICH Q10. The ability to analyse and trend data is now an essential survival skill. This pharmaceutical training course will show you how to do this simply and effectively.

The provision of useful information is essential to the Qualified Person and other professionals.

This course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.

If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Suitability - Who should attend?

The Aspiring Qualified Person

  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional

  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their Continuing Professional Development. Taken with some of our other QP modules, this course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications.

Training Course Content

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 visualization tools
  • Histograms
  • Box plots
  • Confidence intervals
  • Statistical Process Control (SPC) tools:
  • Shewhart, cusum and attribute control charts
  • Pareto charts
  • Fishbone diagrams
  • Process capability (Cp and CpK)
  • ISO 2859 – specification for sampling procedures and tables, application of sampling by attributes
  • ISO 3951 sampling procedures for inspection by variables
  • Regression analysis
  • Statistical testing
  • The t-test
  • Outlier testing
  • Experimental design
  • Multivariate 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?

Why choose NSF International, Pharmaceutical Services

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert pharmaceutical training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider


Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...

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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
YO62 6AF York


Average rating 4.5

Based on 2 reviews

H. Callaby
Statistics teaching was excellent, made a challenging subject understandable and able to be contextualised.
R. Kreuter
I learnt a lot and made great experience exchange with the other participants.
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Case Study
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