Quality Management in Pharma and Biotech
Starting dates and places
Description
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.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
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 …
Frequently asked questions
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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.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
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
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
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
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 A?airs
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 Quali?ed 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
Go to https://pcs-nl.com/training-courses/ for more information
about the modules, the program, trainers, pricing and
registration.
Discount when following all four modules: 20%.
Master and PhD students receive a discount of 25%.
Certificates & Accreditation
You will receive a certifcate 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.
Do you want to register for this training, this is possible through our website: https://pcs-nl.com/product/quality-management-in-pharma-and-biotech/. Or send us an email at courses@pcs-nl.com.
PCS - The Practical Compliance Specialists since 1990
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