Statistical Process Control

NSF International, Pharmaceutical Services
Course summary
2 days
1,420 GBP excl. VAT

Course description

Statistical Process Control

Are you data rich but information poor? This pharmaceutical statistics training course will provide you with the essential understanding of several fundamental statistical process control tools for analyzing data and 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.

Are you data rich but information poor? The pharmaceutical industry has historically underutilized statistical process control (SPC) 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.

New EU and US GMP process validation guidance is emphasizing the need for ongoing/continued process verification by the trending of data; i.e. EU GMP Annex 15, ICH Q10 and the US guidance on process validation. 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 being available to do the ‘number crunching’. However, in order to obtain maximum benefit from the use of these sophisticated statistical software tools it is also vital that the outputs are correctly interpreted.

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

*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.

Training Course Content

Course Outline
Summarizing and Visualizing Data
- How to present and compare data in ways that make understanding easier

Confidence in Your Means and Proportions
- Explains the importance of calculating ‘confidence intervals’, not just means

Control Charts
-How to draw and understand the most common SPC tool for trending data

Cusum Charts
- Explains the control chart that magnifies gradual trends

Fishbone Diagrams and Pareto Charts
- Simple tools for performing cause and effect analysis

Process Capability
- Explains how to determine if a process is capable of consistently meeting pre-defined specifications

Regression Analysis
- How to analyze stability data

We provide an optional post-course assessment that verifies proficiency of all course attendees.


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

About provider

pharma training courses

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

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