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The API and Excipients course content is aligned to the UK QP study guide. It provides the understanding and knowledge of:

• the influence of manufacturing pathways and the associated physical and physicochemical attributes of API and excipients
• the physicochemical and biological properties of API and excipients and the impact of solvents, catalysts, and process aids
• the common manufacturing steps and the principles of process validation for chemical and biological active substances
• good manufacturing practices applicable to API and excipients, including controls to prevent or reduce impurities, contamination (including adventitious infection agents (such as TSE)
• control of supply chains
• the role of the EDQM and Certificates of Suitability (CEP)
• the role of the marketing authorisation holder (MAH) in auditing and providing API QP Declarations
• the impact on the final dosage form

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 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 in delivered in person at the Maidstone Innovation Centre or online.