Quality Management - The role of the Qualified Person
Quality Management - The role of the Qualified Person
Quality Management - exploring the role of the Qualified Person
for pharma & biotech
English Dutch
4 days in total
07-03-2022
What will you learn?
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
Training contents
Subject to changes. The final program will be sent to the participants approximately 1 week before the start of the training.
Training description
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.
Target audience
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.
Course Structure
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.
Learning goals
After having followed this course, you will be able to:
- Apply the basic principles of quality management from a regulatory and business perspective, including:
- 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.
- Specific regulatory responsibilities of senior management, functional leaders, the Quali ed Person and Responsible Person
Results
After having followed this course, you will have:
- 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.
- Thorough understanding of the specific regulatory responsibilities of senior management, functional leaders, the Qualified Person and Responsible Person.
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 Senior Management, the Qualified Person and the Responsible Person
- Quality Management System elements: deviation management, change control, validation & qualification, training and qualification of personnel, customer complaint management, audit systems, third party operations including risk management and data integrity
- Trending, and management reviews
- Lean Manufacturing and Quality Management
- Similarities and differences between local (small) organizations and global (large) organizations
- Current regulatory developments and inspection highlights
- Inspection Readiness: How to manage a regulatory GMP inspection
- The critical impact of culture and behavior on compliance
- QP experiences
- Industry, hospital environment, international setting
- Real-life challenges: APIs, excipients, QP declarations, the Falsified Medicines Directive (FMD), 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 course sessions.
More Information
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).
Course leader
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.
Quality Course modules
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.
Instructors
Désireé Vendrig
Trainer
Désirée Vendrig is an independent GxP consultant, Qualified Person, Responsible Person and trainer.
