This training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical and biotechnological industries and hospitals to safeguard the quality of their products. There will be a focus on the role and responsibilities of the Qualified Person (QP) as well as on legislation, guidelines and best practices. We will also discuss common challenges a QP encounters in his/her day-to-day activities. You will participate in a team to work out a case study in the period between the first and second training sessions.
The Qualified Person watches over product quality while taking patient safety and product availability into account. This requires an in-depth understanding of the role and responsibilities of the Qualified Person. This training is divided into two parts: Block A and Block B. The total duration is five days.
This training is of an advanced level. A basic level of GMP knowledge is required to attend this training. The training program is not designed to address the basic theoretical principles of GMP. The practical implication of the GMP principles, real-life cases and the role of the QP are the focus of this training. A Qualified Person is expected to be aware of a number of pre-approval elements: an overview of the product life-cycle, Toxicology and the Registration Dossier. The training is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies. The self-study prior to the module consists of reading preparatory materials.
