Public-registration training

Quality Management in Pharma and Biotech

4.0 rating based on 1,977 ratings 4 rating based on 1977 ratings.
Four modules offering an integrated approach to quality management in pharma and biotech, and in hospitals, to safeguard the quality of their products.

This training includes:

Register now!

Quality Management in Pharma and Biotech

Four modules offering an integrated approach to quality management in pharma and biotech, and in hospitals, to safeguard the quality of their products.

4.0 rating based on 1,977 ratings 4 rating based on 1977 ratings.

13 days in total
1977 students

Quality Management in Pharma and Biotech

What you will learn

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

Basic qualifications for your Qualified Person (QP) status application after successful completion of all four exams, combined with a relevant university degree

Tell us what you want to learn. Get free learning advice by clicking here!

Training language(s)

Training 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.

Previously organized by PAO Farmacie, now by PCS Academy.

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).

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.

All modules

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: €8.550 (including 20% discount).
All four exams can be taken for €2.200, and will be awarded a Certificate of Achievement for each Module if passed.

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.

Training program

The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.

Training date(s)

Need training sooner?
Click here to get personal training options.

Lecturer(s)

Aad van de Leur
Aad van de Leur
Module Leader, Senior GMP Consultant & Trainer

Aad is working at Byondis BV as COO and is responsible for all Biopharmaceutical operational activities. He had worked for over 23 years at different Biotechnology departments at Diosynth and Organon/Schering-Plough.
Show more
Show less

Christine Mitchell
Christine Mitchell
Module Leader, Senior GCP/GLP Consultant & Trainer

Christine has provided Quality Assurance regulatory compliance support for over 35 years. She has presented at international conferences and participated in various OECD GLP expert working groups. This involved updating the OECD GLPs and developing OECD GLP consensus documents for short-term studies and multi-site studies.
Show more
Show less

Désirée Vendrig
Désirée Vendrig
Module Leader, Senior GMP/GDP Consultant & Trainer

Désirée is an independent GxP consultant with 30+ years experience in the pharmaceutical industry. Désirée fulfilled various Global Quality positions at Teva Pharmaceuticals between October 2004 and January 2018 and was responsible for the quality and compliance of Teva commercial and clinical trial products distributed in Europe and the EMIA-APAC region as well as for quality oversight of third-party manufacturers. Her last assignment was Global Head of Quality for PGT Healthcare, a joint venture between Procter and Gamble and Teva for OTC products. She represented Teva as Co-Chair in the Quality and Compliance Working group of Medicines for Europe and attended several meetings with the Europe Medicines Agency. From 1995 to 2004 Désirée was Senior GMP inspector at the Dutch Healthcare lnspectorate in Haarlem and The Hague. She attended lnspectors Working Party meetings in London and PIC/S conferences, and was involved in the implementation of the Clinical Trial Directive into the Dutch legislation. She started her career in the pharmaceutical industry by joining Solvay Pharmaceuticals (now Abbott) in Weesp, The Netherlands in 1988 as Head of the R&D Pharmaceutical Analysis Department. In this role she was among others responsible for the release of raw materials and finished products for pre-clinical and clinical trials. Désirée graduated in 1985 as a pharmacist at the State University of Utrecht, The Netherlands. In the same year she started her PhD study at the Faculty of Pharmacy of the University of Utrecht resulting in the thesis titled Bioanalysis Stability, Pharmacokinetics and Electrochemistry of Vinca Alkaloids. During her period at the Faculty of Pharmacy, Désirée delivered practical education to Pharmacy students. She has given more than 15 years' GMP lectures fora post-academie course on Radiopharmacy organised by the European Association of Nuclear Medicine (EANM) and regularly lectures on GMP and GDP at national and international courses and conferences. She works as an independent consultant.
Show more
Show less

Jos Mathôt
Jos Mathôt
Module Leader, Senior GMP Consultant & Trainer

Jos has over 35 years of experience working with sterile pharmaceuticals and aseptic production. He was operations manager at Organon and site leader of a pharmaceutical isotope manufacturing organization.
Show more
Show less

Aad van de Leur
Christine Mitchell
Désirée Vendrig
Jos Mathôt

Registration

To start your registration, first select the start date of the training, then fill in the form below.

Start dateEnd dateVenuePriceStatus

Upon passing the exam, you will receive a Certificate of Competence. The exam is optional.

Participants
Select the number of participants you are registering.

- +

Register now!

Register for this training by clicking the button.
Register for this training

General information

€ 8.550 ex. VAT

Registration is closed.
Register now!
This training includes:

Training certificate

Lunch buffet

Train more than 5 people?

An in-house training is your best choice! We have more than 100 GxP in-house training courses on request.

Go to in-house training

Register now!

Register for this training by clicking the button.
Register for this training