九州影院

Course overview

The Qualified Person should have a thorough knowledge of 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.

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 are two versions of this course, a two day course (run in March & November) and a three day course (run in June & December). The three day course includes a practical day to gain hands-on experience in the preparation and evaluation of some formulations. If you do not need the practical day because you have enough hands-on formulation experience you may be better suited to our February course.

Prerequisites

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.