Public-registration training
Quality Management – The Role of the Qualified Person

Quality Management - The role of the Qualified Person
Quality Management – The Role of the Qualified Person
Identify elements of applicable GMP regulations and GMP expectations across the product life-cycle
Understand current regulatory developments and their business impact, e.g., new regulations, the Falsified Medicines Directive (serialization) and significant issues that may impact the business (data integrity, drug shortages and supply chain integrity),
Apply the basic principles of quality management from a regulatory and business perspective
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The training
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.
Target audience
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).
Accreditation will be sought with the NVZA and KNMP (hospital and public pharmacists).
What is the training about?
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.Training structure
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.
Content· 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.36 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.
Program - eLearning Component Lecture Sub-lectures Program - Day 1 Lecture Sub-lectures Day Introduction: The Roles and duties of the Qualified Person in Pharmaceutical Quality Management (Annex 16 and importation) 1 Roadmap to realize Sustainable Quality and Regulatory Compliance Performance The Specific Regulatory Role and Responsibility of Senior Management, the QP and RP (IGJ) 1 Deviation & CAPA Management with RCA Case Case study1 Change Control Case study1 Complaint handling to recall (QP involvement) 1 QP skills & challenges 1 Training, Qualifications and roles & Responsibilities Workshop1 Program - Day 2 Lecture Sub-lectures Day Validation & qualification Case met validatieprotocol/rapport2 API & Excipients and RCA's 2 QP Declaration 2 Trending and Management review and QP involvement 2 Dilema's of an international QP 2 Challenges of a QP in Industry 2 Grey area QP role in Hospital environment 2 QC 2 OOS and batch decision: release or reject Case2 Program - Day 3 Lecture Sub-lectures Day Quality Culture & Behavior Theory and workshop3 Lessons from the Case Study Quality Culture & Behavior 3 Risk Management 3 Deviations 3 Current regulatory development and inspection highlights (IGJ) 3 Q & A session 3 Program - Day 4 Lecture Sub-lectures Day 3rd party operations 4 Data Integrity 4 MAH responsibilities 4 The registration dossier - its development and life-cycle 4 The QP and the registration dossier 4 Drug shortages prevention (CBG) 4 From R&D lead to development active substance to pharmaceutical formulati Presentation and case study4 Program - Day 5 Lecture Sub-lectures Day The critical points in scaling-up (process from development to clinical to commercial) 5 Toxicology & HBEL's 5 GLP basics 5 The role of the QP in clinical studies (GCP) Presentation and workshop5 Safety and Pharmacovigilance 5 Workshop 5 Closure 5 Start date End date Venue Price Status 18-04-2023 25-05-2023 Van der Valk Amersfoort € 3.225 ex. VAT Open for registration Need training sooner?Click here to get personal training options.Désirée Vendrig
Module Leader, Senior GMP/GDP Consultant & Trainer
Christine Mitchell
Module Leader, Senior GCP/GLP Consultant & Trainer
Désirée Vendrig
Christine Mitchell