Quality Management - exploring the role of the Qualified Person
for pharma & biotech
4 days in total
Apply the basic principles of quality management from a regulatory and business perspective
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), and understand the significant impact of behavior and culture
Subject to changes. The final program will be sent to the participants approximately 1 week before the start of 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 QP’s role and responsibilities.
Previously organized by PAO Farmacie, now by PCS Academy.
Professionals in pharmaceutical, biotechnological and medical device industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students.
The course is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance or Regulatory Affairs 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 course is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).
Accreditation is granted for hospital and public pharmacists!
What is it about?
This training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical, biotechnological, medical device industries and hospitals to safeguard the quality of their products. There will be focus on the role and responsibilities of the Qualified Person (QP) as well as on international legislation, guidelines and best practices.
We will also discuss common challenges a QP encounters in the day-to-day activities. You will participate in a team to work out a case study in the period between the first and second course sessions.
Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry, academia and national regulatory authorities such as Dutch IGJ will share their wealth of experience and knowledge during the course.
The course is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies.
After having followed this course, you will be able to:
After having followed this course, you will have:
Go to Quality Management in Pharma and Biotech for more information about the modules.
Date 7-8 March & 6-7 April 2022
Location Hotel van der Valk, Breukelen
Discount when following all four modules: 20%
Master and PhD students receive a discount of 25%
Prices exclude exam fees
In the event of cancellation, we refer to the general terms and conditions of PCS (www.pcs-nl.com).
Dr. Désirée Vendrig – Vendrig in Pharma
Désirée is a pharmacist by education and holds a PhD in Natural Sciences. She started her career in the pharmaceutical industry as Head of an R&D Pharmaceutical Analysis Department. After 10 years as a Senior GMP Inspector for the Dutch Inspectorate for Healthcare and Youth (then known as IGZ), Désirée fulfilled various Global Quality Management positions at Teva and was a registered QP and RP. Nowadays, Désirée is an independent GxP consultant.
This module is part of a series called: "Quality Management in Pharma and Biotech". This series is designed to give participants an in-depth understanding of the QP’s role and responsibilities. See the other modules in this series below.
Désirée Vendrig is an independent GxP consultant, Qualified Person, Responsible Person and trainer.