Course Overview
The Qualified Person should have a thorough knowledge of formulation and processing of the medicinal products they are asked to certify.
The full course is structured over six-days and split into two parts. The course 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.
The course includes exercises on typical situations for the trainee QP to practice decision-making. Sessions on other key areas that a QP must understand including process validation and scale-up, facility design, utilities and sterilisation processes are included.
There is an optional laboratory practical day offered that enables delegates to gain hands-on experience in the preparation and evaluation of some formulations.
Who Should Attend
This is a crucial module for QPs who are, or who will be involved in certifying commercial or investigational batches of medicinal products. The course is most suitable for delegates with no prior or a basic knowledge of the subject however would be of benefit to the more experienced.
