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.
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).
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.
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.
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.
See all modules in this course below. 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: €7650 (including 20% discount).
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. 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.