Quality Management in Pharma and Biotech
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.
for pharma & biotech
Languages:
13 days in total
This training's start date is guaranteed
What will you learn?
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
Instructors
Désireé Vendrig
Trainer
Désirée Vendrig is an independent GxP consultant, Qualified Person, Responsible Person and trainer.
Jos Mathôt
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.
Ineke Jonker-Hoogerkamp
Trainer
Ineke is an independent consultant in regulatory affairs and drug development. She has over 25 years of experience in regulatory affairs.
Aad van de Leur
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.
Training description
The training
Previously organized by PAO Farmacie, now by PCS Academy.
Target audience
Learning goals
- 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
- 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
All modules
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 contents
Training dates
Quality Management in Pharma and Biotech
This course has no fixed starting date or combines several other courses or modules that have fixed starting dates. The moment of registration determines which module or course you can attend first.
7650.00
Languages
- English spoken languageDutch secondary spoken languageEnglish course materials
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.
