Learn the essential elements of the Quality Control laboratory and In-Process control checks used in the pharmaceutical industry.

This course meets the requirements of the UK QP study guide, however, it is also useful for anyone looking for an overview of the Quality Control testing of medicines.

  • Key topics

    Samples and Sampling for QC

    BP / EP / USP

    Method development, validation and transfer

    Out of Specification process

    Chemical and Biological testing methods

    Key methods in more detail:
    Chromatography
    Dissolution

  • Main Tutors

    Tanya Agombar (In Person)

    David Price (In Person)

    _________________________

  • Included

    Data Integrity for the QC laboratory

    Workshops, exercises, assessment

    Leadership for the QP

    Form and viva practice

Learning outcomes

The testing that a pharmaceutical product undergoes throughout its production needs to be reliable and provide accurate and meaningful answers.
This course provides the aspiring QP with the background and technical knowledge to be able to assure through oversight that the testing meets these criteria.

  • Learn about the various key activities conducted by the Quality Control laboratory, including:
    # Sampling and sample management
    # Routine finished product testing
    # Method and cleaning validation testing
    # Storage and analysis of routine stability samples
    # Stability studies to determine product shelf life
    # Evaluation and reporting of results

  • Gain an overview of the key analytical techniques used in the quality control laboratory, including:
    # Chromatography (inc HPLC)
    # Spectroscopy
    # Titrimetric / Gravimetric
    Electrochemical, e.g. pH

  • Understand the requirements for analytical method development and method validation
    # As outlined in the updated ICH Q2 and new ICH Q14

  • Understand the requirements of Good control Laboratory Practice (GcLP), including:
    # Documentation control
    # Management of Pharmacopeial monographs and methods
    # Management of OOS/OOT/OOE results
    # Data Integrity

In this portal

Your materials, assignments and assessments will all be provided through this learning portal

You will be notified by email when items are available for you to access...

  • 1 month before the course start date
    ~ You can access your course workbook
    ~ You will be able to download your Preparatory Assignment

  • Day before course start date
    ~ Downloads for workshops and exercises

  • End of each course day
    ~ Answers to exercises where appropriate

  • After course
    ~ Learning assessment
    ~ Course evaluation
    ~ Certificate

Where Are We?

Location: Maidstone Innovation Centre,
Gidds Pond Way, Weavering, Maidstone, Kent ME14 5FY

Maidstone is very accessible by car, with the M2 and M20 motorways providing easy connections to the M25.

Southeastern run trains across the county and Maidstone town centre benefits from two railway stations. Maidstone East connects to London and Ashford, while Maidstone West links to Gatwick and Tonbridge.
how to find us

Want to know more, find out about the discount bundles available, or book your training

Call us directly on
01622 477781
email us
[email protected]
or pop your email in the box below and we will get right back to you

Thank You