QP Active Pharmaceutical Ingredients - eLearning Knowledge Reinforcement

2.00 Hour/s

CPD Hours: 2

eLearning

The focus of our QP Knowledge Reinforcement modules, is to provide a means for Trainee QPs to review the key information from the course content previously covered in the Tutor led course (whether delivered by RSSL or another supplier) and then test their knowledge.


The eLearning QP Knowledge Reinforcement module for Active Pharmaceutical Ingredients reviews 8 key sections from the tutor led course and has 118 questions, to test your knowledge and ensure you know the subject matter, ready for your Viva.


There are two elements to each section :


  • Content review
  • Assessment/Questionnaire

The assessment/questionnaire is based on a mixture of question styles. You are required to get 80% of the questions correct and have 3 attempts to do so, after which you will be asked to take the section and the assessment again.


The eLearning QP Knowledge Reinforcement module for Active Pharmaceutical Ingredients, is suitable for any Trainee QPs that have previously attended an Active Pharmaceutical Ingredients, Tutor led course (whether delivered by RSSL or another supplier) and want to test their knowledge in readiness for their Viva.

The module covers the following content and questions related to the following topics:

  • General review
  • Manufacture of Synthetic Chemical Active Substances
  • Manufacture of Biological Active Substances
  • Falsified Medicines and Sourcing of Active Substances
  • Registration
  • Control of active substances
  • Validation
  • Packaging materials

    At the end of the course you will have reinforced your knowledge, on the following :


    • The role of the QP relevant to APIs
    • The regulatory framework for the manufacture of APIs
    • The requirements of the Falsified Medicines Directive and APIs
    • How to use the European Guide to GMP for APIs
    • The contents of a drug master file
    • Methods and equipment used in synthesis
    • Requirements for specifications, organic solvents and impurities
    • Process and cleaning validation
    • The control of packaging materials for an API

£ 170

ex VAT

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