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. Previously organized by PAO Farmacie, now by PCS Academy. This training is divided into two parts:

1. April 9 to April 10 2024,
2. May 14 to May 16 2024.

Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and CRO’s, Hospital pharmacists and Postgraduate students.The training is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control and Quality Assurance who are dealing with complex quality systems. The target audience needs to gain an in-depth understanding of these systems to improve quality management in their own organization. The training is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands). The training has been awarded 30 accreditation points for hospital pharmacists at the NVZA (cursus ZA).

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.

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. We therefore strongly recommend following this training in conjunction with the "GMP voor het Middenkader" training, the upcoming edition of “GMP voor het Middenkader” will be held on 21-23 March 2023. Participation in “GMP voor het Middenkader” is offered at the reduced rate of €1250.- ex. VAT when purchased together with this training. “GMP voor het Middenkader” is a proven training that provides an overview of the key aspects of quality management. All nine chapters of the GMP are covered, laying an important foundation for this training; Quality Management - the role of the QP . If you have a sufficient level of GMP knowledge going into this training, it is possible to obtain exemption from following “GMP voor het Middenkader” by taking a multiple-choice test. The result of this test is non-binding. A Qualified Person is expected to be aware of a number of pre-approval elements, which is why have incorporated a new set of elements in this module; 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 and following eLearnings.