The training

The ''Quality Management in Pharma and Biotech'' course, first organized in 1997, has successfully given hundreds of (aspiring) Qualified Persons and other quality professionals a solid basis to fulfill their essential role in the pharmaceutical industry and hospital pharmacies.

Previously organized by PAO Farmacie, now by PCS Academy.

The four modules

The four modules of the “Quality Management in Pharma and Biotech” course are:

1. Quality Management - The role of the Qualified Person
Date: 7-8 March & 6-7 April2022
Module 1 focuses on the role of the Qualified Person (QP) and how Quality Management systems safeguard product quality, besides being good business practices. The QP 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.

2. Quality Management in Drug Development – from Quality by Design to clinical studies
Date: 20-22 September 2022
Module 2 explores the regulatory requirements for drug development from both a quality viewpoint as well as an inspection bodies, Regulatory Affairs, and Drug Registration Authorities perspective. We will explore the development of a new Active  Pharmaceutical Ingredient (API), following the principles of Quality by Design. Then non-clinical development is discussed, including toxicology, up to clinical development and manufacturing, referring to GLP, GCP and GMP requirements and regulatory guidelines.

3. Quality Management in Sterile Manufacturing – a thorough discussion on sterility assurance challenges
Date: 11-13 October 2022
Module 3 focuses on the development and manufacturing of sterile pharmaceuticals. The challenging environment in production requires expertise in microbiology and control systems specific for sterile manufacturing. Implementation of this expertise in the design and control of processes is crucial. Contamination factors and environmental control both influence several steps in the production process and will be discussed extensively.

4. Quality Management in Manufacturing of Biopharmaceuticals – from cell line development to downstream processing and formulation
Date: 22-24 November 2022
Module 4 addresses the development of biopharmaceuticals and how this relates to quality aspects. In this module, we will consider the critical steps of developing cell lines, upstream and downstream processes, and commercial production up to protein analysis. Stability, comparability, contamination and immunogenicity will be discussed, as they require special attention compared to API's of non-biological origin.

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).

Learning goals

After having followed all four modules, you will be able to:

• Find, interpret and understand relevant GxP guidelines and apply the principles in complex cases.
• Employ concepts and data to achieve compliance and quality for all phases of drug production from early development, clinical testing and manufacturing until final distribution of the product.
• Make decisions based on facts and regulatory expectations. You will be able to explain the rationale of your choices and defend your point of view.

Results

After having followed all four modules, you will have:

• Basic qualifications for your Qualified Person (QP) status application after successful completion of all four exams, combined with a relevant university degree.
• Gained a clear overview of the essential quality systems required to improve quality management in your own organization.
• Thorough theoretical and practical knowledge on compliant QP product release, safeguarding the final quality of products administered to patients.

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.

More Information

 Click on the modules for more information about the modules, the program, trainers, pricing and registration.

Module 1

Module 2 

Module 3

Module 4

Discount price when following all four modules: €7036 (including 20% discount. Price for 2022, inquire about the price when following a module in 2021).

Master and PhD students receive an extra discount of 25% per module.

In the event of cancellation, we refer to the general terms of condition of PCS (www.pcs-nl.com).

All modules are organized in the area of Utrecht, The Netherlands.

Certificates & Accreditation
You will receive a certificate of attendance after attending a module. Additionally, you are offered the possibility to achieve full completion of the modules through an examination. The examination sessions will be scheduled twice a year. In combination with a university degree in, e.g. pharmacy, biology, chemistry or (bio)pharmaceutical sciences, and with relevant practical experience, successful completion of all modules of the training course forms a good starting point to apply for a Qualified Person (QP) status.

PCS will apply for accreditation for each individual module with hospital pharmacists’ professional association NVZA.