The Qualified Person should be the company expert in formulation and processing of the medicinal products they are asked to certify. This six-day (two part) module provides basic formulation principles, including preformulation studies, bioavailability considerations and the effect of excipients on physical and chemical stability. Each major product category is considered separately with respect to common formulations and processing techniques and the course includes exercises on typical situations for the trainee QP to practise decision-making. The course includes sessions on other key areas that a QP must understand including the Annexes of the Orange Guide, process validation and scale-up, facility design, utilities and sterilisation processes. Part One of the course includes a practical day to gain hands-on experience in the preparation and evaluation of some formulations.