Quality Management in Pharma and Biotech (Module 1 to 4)

Four modules oﬀering an integrated approach to quality management in pharma and biotech.

Based on 2.089 participants

GMP & GDP training for pharma & biotech

Language:
13 days in total

€ 9135 ex. VAT

This training contains:

Lunch

Course dinner

Digital copy of materials

Training certificate

Certificate of competence

Training Dates

This course combines a number of modules that have fixed starting dates. The moment of registration determines which module or course you can attend first.

The modules included in this course are:

Module	Dates	Language	Can I attend this module this year?
Module 1 Quality Management – The Role of the Qualified Person	This module was organised in Mar 2026. The next available edition starts on Sept 2026.	English spoken language (primary)	Yes.
Module 2 Quality Management in Drug Development	This module was organised in May 2026. No new edition for this module has been planned.	English spoken language (primary)
Module 3 Quality Management in Sterile Manufacturing	This module was organised in Oct 2025. The next available edition starts on Oct 2026.	English spoken language (primary)	Yes.
Module 4 Quality Management in Biopharmaceutical Manufacturing	This module was organised in Nov 2025. The next available edition starts on Nov 2026.	English spoken language (primary)	Yes.

Quality Management – The Role of the Qualified Person

This training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical...
Quality Management in Drug Development

This training program is designed to equip professionals in the pharmaceutical industry and hospital pharmacies with the...
Quality Management in Sterile Manufacturing

The sterility of a pharmaceutical product can only be assured when a series of control measures are in place. The sterility...
Quality Management in Biopharmaceutical Manufacturing

Biopharmaceuticals are the next generation of medicines. As they originate from live cells, there are several quality concerns...

It is not required to follow the modules in sequential order.

Description

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.

Target Audience

Professionals in pharmaceutical and biotechnological 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).

When there are no English-speaking participants, the course language will default to Dutch.

If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,

(University) Students

Master's and PhD students get a discount of 25% per module/programme.

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.

All four modules

It may be that some modules have been fully booked, in that case, you may need to follow a module in the subsequent year. Contact PCS for more information.

Discount price when following all four modules: €9135 (including 20% discount). All four exams can be taken for €1.400,00 and will be awarded a Certificate of Achievement for each Module if passed.

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. 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.

Programme

Practical Information

Difficulty / Level:: Intermediate level and Professional level
Group discounts:: 2 participants - 5%

3 participants - 10%

4 participants - 15%

4 participants - 20%

6+ participants - 25%

Group discounts are only applicable when multiple participants register for the same course at the same time.
Languages throughout the modules:: English spoken language (primary)

Dutch spoken language (secondary)

Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
Learning form:: Classroom
Requires preparation:: Yes.
Every module in this series contains homework.
Includes exam:: Yes.
Exam price:: €1,400.00 ex. VAT per participant.