Interpretation of Statistical Values used in GMP Applications

1 Day/s

CPD Hours: 7

Online, in-house

Provides individuals working in pharmaceuticals an understanding of the application of statistical tools their practical usage.

Evaluation of data using statistical techniques is a key element of controlling the quality of pharmaceutical products for human and veterinary use. It is important to understand application of the data with which they will be presented. 

Special Offer - if you book this course, you will receive a £350 discount on our QP Mathematics and Statistics course (excludes Trainee QPs on packages). 

This course is suitable for those working in pharmaceuticals who have little or no previous statistics experience and also Trainee QPs before attending our QP Mathematics and Statistics module. The course is relevant to any Individual wishing to understand the application of statistical tools and their practical usage of appropriate techniques in various aspects of pharmaceutical quality system such as product quality review, sampling, environmental monitoring analytical method validation, stability system and temperature excursions. This course provides the synopsis of mathematics and statistics module as per the QP study guide.

Course includes the following topics :

  • Application of statistics – EU GMP guide references
  • Application and interpretation of control charts
  • Statistical interpretation of analytical method validation
  • How to use and apply AQL in various GMP scenarios
    • By the end of this course, you will learn :

      • Gain understanding of statistical tools and their practical application in pharmaceutical quality system – what, when and how?
      • Understand the questions you should ask about data collection, interpretation, integrity and analysis

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    Bring this course in-house

    Special offer

    Helping your training budget go further

    We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

    Meet the tutors

    Zoe Betteridge

    Zoë obtained her PhD from the University of Bath and the Department of Health working on the optimisation of vaccine production. She then spent over 10 years working as a research fellow identifying novel autoantibodies and determining their role as clinical biomarkers. This incorporated the development and validation of multiple diagnostic assays, development of complex diagnostic algorithms and the formation of an accredited diagnostics service . Zoe is currently employed by Accord UK as a Senior Scientist & Chemometrician. Her role covers a range of expertise including preparation of regulatory filings and investigational medicinal product dossiers, review of updates to ICH guidelines and acting as a subject matter expert in statistics and data analysis, where she is experienced in using a range of analytical software programmes and training statistical methods.

    Related Course

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    QP mathematics and statistics

    If you book our Interpretation of statistical values used in GMP applications course, you will receive a discount of £350 (15%) off our QP mathematics and statistics course (excludes QP Trainees on packages)