Quality Management – The Role of the Qualified Person

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. 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 in March. 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.

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).

 •    Thorough understanding of the specific regulatory duties and responsibilities of senior management, functional leaders, the Qualified Person and Responsible Person.
•    Insight into the integrated approach on Quality Management to safeguard product quality.
Tools to realize and improve, pro-actively and on an ongoing basis, effective quality management across the various stages of the product lifecycle.

• Quality Management as a good business practice across the product life-cycle
• Basic Principles of Quality Management
• The specific regulatory role and responsibility of the Qualified Person
• Quality Management System elements: deviation management, change control, RCA, validation & qualification, training and qualification of personnel, customer complaint management, audit systems and third-party operations
• Similarities and differences between local (small) organizations and global (large) organizations
• Current regulatory developments and (IGJ) inspection highlights
• The critical impact of culture and behavior on compliance
• Trending, Management Reviews and QP involvement
• The Registration Dossier: it’s development, life-cycle and the role of the QP
• Toxicology, including Health Based Exposure Limits
• From development to clinical to commercial
• QP experiences
• Industry, hospital environment, international setting
• Real-life challenges such as QP declarations and drug shortage prevention
• Real-life case studies
• Including participation in a team to work out a case study in the period between the first and second training sessions.