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The Analysis and Testing course is mapped to the UK QP Study guide. The learning outcomes are:

Key activities performed by the quality control laboratory:

• 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

Key analytical techniques used in the quality control laboratory, including:

• Chromatography (including HPLC)
• Spectroscopy
• Titrimetric / Gravimetric/Electrochemical, e.g. pH

Understanding the requirements of Good Laboratory Practice (GLP) and Documentation control:

• Management of Pharmacopeial monographs and methods
• Management of OOS/OOT/OOE results
• Data Integrity

Understanding the requirements for analytical validation and analytical procedure development as outlined in the revised ICH Q2 and new ICH Q14 respectively.

QPQuandary Ltd use a mixture of presentations, exercises (scenarios), and workshops to help delegates incorporate the necessary technical knowledge, leadership, and interpersonal skills, required to meet their aim of attaining the position of Qualified Person (QP).

Training is delivered by QPs and Subject Matter Experts from the Pharmaceutical Industry.

The course is interactive, with materials, assignments and assessments provided through a learning portal. Delegates must complete pre-course work, end of day exercises and post coursework.

A certificate is issued on completion of the course and assignments.

Prerequisites

The course is suitable for delegates working towards the role of the Qualified Person and for existing QPs and Quality Professionals involved in manufacturing medicines, who wish to maintain Continuing Professional Development.

Additional information

The course is offered instructor led either in person at the Maidstone Innovation Centre or on-line.