Quality Management in Biopharmaceutical Manufacturing
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Quality Management in Biopharmaceutical Manufacturing

Three days on manufacturing biopharmaceuticals & quality aspects

  • Based on 560 participants

GMP & GDP training for pharma & biotech

  • Language:
    English flag
  • 3 days in total

€ 2590.00 ex. VAT

Registration ends in 139 days.

Register now!

The upcoming start date of this training is guaranteed.

This training contains:
  • Accreditation for ziekenhuisapothekers (NVZA), 18 accreditation points
  • Lunch
  • Course dinner
  • Digital copy of materials
  • Training certificate
  • Certificate of competence

    • What you will learn

    Apply critical process parameters (CPP) and critical quality attributes (CQA) for biopharmaceuticals to achieve a robust process

    Understand how relevant test methods are best applied and what their limitations are

    Understand how biopharmaceuticals are produced and what the differences are between small

    and large (biopharmaceutical) molecules, including the key process units for cell line development,

    upstream and downstream processing and how they impact product quality

    Training Dates

    Quality Course Modules default to English, but will be in Dutch if all attendees are Dutch-speaking.

    Dates Language Price Register
    11/18/25 to 11/20/25 English spoken language (primary) € 2590.00 Register
    11/24/26 to 11/26/26 English spoken language (primary) € 2719.00 Register

    Description

    The Training

    Biopharmaceuticals are the next generation of medicines. As they originate from live cells, there are several quality concerns and significant technical challenges during development, manufacturing and testing.

    This module provides participants with a solid understanding of the production of biopharmaceuticals, and critical aspects to understand during development.

    Target Audience

    Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Post-graduate 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).

    This training is also suitable for ziekenhuisapothekers, who will receive professional accreditation points.

    (University) Students

    Master students get a discount of 25% per module/training.

    Results

    After having followed this course, you will be able to:
    • Understand how biopharmaceuticals are produced and what the differences are between small and large (biopharmaceutical) molecules, including the key process units for cell line development, upstream and downstream processing and how they impact product quality.
    • Apply critical process parameters (CPP) and critical quality attributes (CQA) for biopharmaceuticals to achieve a robust process.
    • Understand how relevant test methods are best applied and what their limitations are.
    • Understand the up-to-date information on relevant ICH guidelines and have the knowledge where to find EMA and FDA guidance for biopharmaceuticals;
    • Apply the knowledge to achieve a compliant QP release of biopharmaceutical products according to the appropriate expectations.
     

    Results

    After having followed this course, you will have:
    • The knowledge to achieve a compliant QP release of biopharmaceutical products according to the appropriate expectations, including awareness of how process changes and small differences may impact quality and safety, including immunogenicity.
    • Fundamental tools to achieve a robust manufacturing process and insight into how CPP’s and CQA’s are established using different approaches.
    • Up-to-date information on relevant ICH guidelines and knowledge where to find EMA and FDA guidance for biopharmaceuticals.

    Contents

    • Introduction to biotechnology
    • Upstream process development for biopharmaceutical products
    • Cell line development and cell bank preparation
    • Purification survey of unit operations and process integration
    • Design of an industrial process for purification of biologicals
    • Development, tech transfer and commercial production of monoclonal antibodies by cell culture
    • Pathogen safety
    • Protein analytics of biopharmaceuticals
    • Critical attributes and comparability studies
    • Quality challenges for Advanced Therapy Medicinal Products (ATMP)
    • Biosimilars: a new class of licensed biotech products
    • Immunogenicity and formulation of biopharmaceuticals

    Program

    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.

    Module Date Length Price
    Quality Management in Sterile Manufacturing
    		Next edition: 10/28/25 3d € 2590.00
    Quality Management in Biopharmaceutical Manufacturing (Current Module)
    		Next edition: 11/18/25 3d € 2590.00
    Quality Management - the Role of the Qualified Person
    		Next edition: 3/24/26 5d € 3485.00
    Quality Management in Drug Development
    		Next edition: 5/19/26 2d € 2495.00

    Practical Information

    Accreditation:
    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.

    Language (upcoming edition):
    • en flag English spoken language (primary)
    • nl flag 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
    Times:
    Starts at approx. 09:00 and ends at approx. 17:30
    Requires preparation:
    Yes.

    This module contains homework. The homework will be provided prior to the training.

    Includes exam:
    Yes.
    Exam price:
    €350.00 ex. VAT per participant.
    Notes to the course dinner:

    The course dinner takes place on day 2.

    Lecturer

    Aad van de Leur avatar

    Aad van de Leur

    Trainer

    Tags

    GMP EudraLex Volume IV Medicines Act Quality Assurance Qualification Quality Culture Manufacturing CCS Sterile Aseptic Biopharmaceutical Qualified Person Quality Awareness QP Skills ATMP Biotechnology Immunogenicity Critical Parameters Purification Tech Transfer Biologicals CQA Pathogen Safety Biosimilars

    Reviews (30)

    4 out of 5 stars

    Based on 30 reviews

    Review data

    5 star reviews

    23%

    4 star reviews

    77%

    3 star reviews

    0%

    2 star reviews

    0%

    1 star reviews

    0%

    4 out of 5 stars

    Strong points (and why):

    Covered broad range of topics in biopharmaceutical manufacturing.

    Marco - QA officer

    5 out of 5 stars

    Strong points (and why):

    Praktische voorbeelden

    Review:

    Mogelijk de 2de dag een uurtje korter door een wat overlap uit een paar zaken te combineren. Bedankt voor de goede organisatie.

    Mike - QP

    4 out of 5 stars

    Strong points (and why):

    Verschillende onderdelen en expertises gecoverd

    Ton - Qa compliance

    4 out of 5 stars

    Strong points (and why):

    De inhoud.

    Review:

    6 uur lang dezelfde cursus is te lang helemaal als het tot 19:00 duurt zonder echt ingeplande pauze.

    Kjell Bakker - Qualified Person

    4 out of 5 stars

    Strong points (and why):

    The workshops and variations in topics.

    Review:

    For the slide please add a list of meaning of abbrevations.

    Elaine - RA manager bloodproducts

    5 out of 5 stars

    Strong points (and why):

    Broad view of biotech.

    Review:

    Afternoon session of the second day could have been a bit shorter.

    Diane Houben - QP

    4 out of 5 stars

    Strong points (and why):

    The deep knowledge of the presentators.

    Review:

    Some topics were covered multiple times, for example the CQA. I would replace this with topics that were only shortly covered.

    Emilia - QP

    4 out of 5 stars

    Strong points (and why):

    Broad spectrum of information.

    Review:

    Ask speakers to have more interaction within lectures. F.e. yes/no questions, now it was al lot of listening and information.

    Lou - Student

    4 out of 5 stars

    Strong points (and why):

    I liked the interactive and passionate presentations and workshops and that the entire chain of development and production was covered

    Review:

    Personally, I would add more interactive parts (green/red or ABCD, mini workshop) in the first day and morning of the 2e day.

    Marten Hansen - Head Laboratory for Cell Therapy, Sanquin

    4 out of 5 stars

    Strong points (and why):

    Workshops van enkele sessies.

    Review:

    Meer interactieve werkvormen. De theorie is taai en lastig in 1x te onthouden. Graag ook huiswerk vooraf om in te lezen zoals bij QP module 1.

    Anonymous - Hoofd QA

    4 out of 5 stars

    Strong points (and why):

    Er zijn veel verschillende aspecten van het onderwerp aan bod gekomen.

    Review:

    Sommige presentaties waren nogal lang en niet interactief, andere waren juist heel interactief. Een tip kan zijn om docenten te vragen de presentaties interactief te maken. Er hoeft niet altijd een workshop bij, maar aan het begin, in het midden en aan het eind een vraag zou al helpen.

    Anonymous - Anonymous

    4 out of 5 stars

    Anonymous - Anonymous

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    Registration ends in 139 days.

    Register now!

    The upcoming start date of this training is guaranteed.

    Difficulty:
    Intermediate level Professional level
    This training contains:
  • Accreditation for ziekenhuisapothekers (NVZA), 18 accreditation points
  • Lunch
  • Course dinner
  • Digital copy of materials
  • Training certificate
  • Certificate of competence
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