Quality Management in Drug Development
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Quality Management in Drug Development

This two-day training provides insight into the regulatory requirements for drug development.

  • Based on 392 participants

GMP & GDP training for pharma & biotech

  • Language:
    English flag
  • 2 days in total

0 ex. VAT

Registration is closed.

Registration closed

This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
  • Certificate of competence
  • What you will learn

    To be able to apply tools and strategies for the development and testing of a product.

    A basic understanding of the clinical and non clinical studies to understand their impact on product development, the risks, and to manage and mitigate them in relation to product quality.

    To be able to assess the right and relevant information about the product to be able to release it for its use in a non clinical or clinical study.

    To enhance knowledge of regulatory requirements and best practices for the development of a pharmaceutical product and its quality to be able to comprehend the regulatory landscape.

    To create an understanding of concepts and principles in pharmaceutical development to understand the risks, manage and mitigate them in the different stages of development.

    Training Dates

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

    Dates Language Price Register
    There are no editions planned for this training, check back soon!

    Description

    The Training

    This training program is designed to equip professionals in the pharmaceutical industry and hospital pharmacies with the knowledge and skills necessary to effectively manage, assess and improve the quality of pharmaceutical products during pharmaceutical product development.

    It focuses on the different stages in development and testing of a product in these phases to be able to determine the relevant issues and critical aspects of the production process and to compile and submit a registration dossier for market approval.

    This course provides a comprehensive understanding of the pharmaceutical development and regulatory affairs landscape, the challenges during development and testing, the impact of gaining knowledge and implementing GMP and developing a pharmaceutical quality system during the different stages.

    Participants will gain practical skills, regulatory knowledge, and ethical perspectives necessary to ensure product quality, patient safety, and compliance with industry standards (GLP/GCP/GMP/ICH).

    It prepares professionals to excel in their roles and make meaningful contributions to the pharmaceutical industry and hospital pharmacies to be able to assess the relevant information in relation to new products for non-clinical studies and IMP’s for clinical studies.

    What is it about?

    This two-day training provides insight into the regulatory requirements for drug development from both the viewpoint of regulatory authorities as well as inspection bodies.
     
    Following the journey of product development from drug discovery to non-clinical and clinical studies, the course touches upon the Registration Dossier and will discuss the GLP, GCP and GMP requirements and guidelines.
     
    Understanding regulatory expectations will ensure professionals minimize delays and clarify the decisions made along the way.

    Course structure

    Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry and academia 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.

    Target Audience

    The course is aimed at:

    • Professionals in the pharmaceutical and biotechnology industry;
    • Professionals in institutions and Contract Research and Manufacturing Organizations (CROs/CMO’s);
    • Hospital Pharmacists;
    • Post-graduate students.

    If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,

    (University) Students

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

    Results

    After having followed this course, you will have:
    • Awareness of the difference between the GxPs and regulatory expectations.
    • Understanding of your role in the drug product development.
    • Knowledge on how to identify gaps in the data package to be submitted for regulatory approval.

    Contents

    • Welcome, Introduction & Personal Expectations
    • Introduction to Drug Discovery - From Patient to Target Product Profile
    • The importance of GMP for IMP's and practical aspects including the role of the QP for IMP
      • Workshop
    • The IMPD and the Registration Dossier
    • Defining the QTPP, CPP & CQA
    • QbD, ATP and Validation
    • Product Development
      • Workshop
    • Pharmacokinetics & pharmacodynamics
    • GLP & Non-Clinical Studies
    • GCP & Clinical Trials
      • Workshop
    • Workshop: Begin with the End in mind!
    • Reflection and closure

    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
    Next edition: 10/28/25 3d € 2590.00
    Next edition: 11/18/25 3d € 2590.00
    No dates planned 5d 0
    No dates planned 2d 0

    Practical Information

    Difficulty / 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):
    • 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:
    To be announced.
    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 1.

    Lecturers

    Christine Mitchell avatar

    Christine Mitchell

    Trainer

    Marel de Wit avatar

    Marel de Wit

    Trainer

    Reviews (34)

    4 out of 5 stars

    Based on 34 reviews

    Review data

    5 star reviews

    18%

    4 star reviews

    59%

    3 star reviews

    24%

    2 star reviews

    0%

    1 star reviews

    0%

    5 out of 5 stars

    Strong points (and why):

    interactive

    Anonymous - Anonymous

    5 out of 5 stars

    Strong points (and why):

    From basic understandings to more in detail topics

    Review:

    Cases are very good exercise

    Anonymous - QA specialist

    4 out of 5 stars

    Strong points (and why):

    Variation in topicstarter, workshops

    Anonymous - Anonymous

    5 out of 5 stars

    Strong points (and why):

    Good balance between lectures and workshops. Enough breaks

    Anonymous - Qa intern/Msc student

    4 out of 5 stars

    Strong points (and why):

    The workshops

    Anonymous - Anonymous

    5 out of 5 stars

    Strong points (and why):

    The case studies. The discussions with the group members and teachers.

    Birke Geurts - RAQA Manager

    4 out of 5 stars

    Strong points (and why):

    The knowledge of the instructers and there was plenty of time for question and discussions.

    Ger Molenaar - QP in training

    4 out of 5 stars

    Strong points (and why):

    Goede afwisseling tussen opdrachten en lectures

    Review:

    Probeer de opdrachten tussendoor iets meer te kaderen vanwege de korte tijd

    Pol Vleer - QA Specialist

    5 out of 5 stars

    Strong points (and why):

    Good preparation

    Anonymous - Sr QA Project Manager

    4 out of 5 stars

    Strong points (and why):

    Interaction and exercises

    Review:

    Regarding the exercises, clearer defined exercises and a bit more time would have been a plus

    Xander - QA Manager

    4 out of 5 stars

    Strong points (and why):

    Training content covers all aspects of drug development

    Review:

    Trainers were well prepared for training and interactions was good. Training is helpful for my career growth.

    Sunil Patil - QP, QA manager

    4 out of 5 stars

    Strong points (and why):

    The interaction with the trainers and other course members was very insightful.

    Review:

    Keep groups small. Trainers were very friendly, knowledgeable, and great in sharing their experience.

    Mike Gielisse - Quality Specialist / QP

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    0 ex. VAT

    Registration is closed.

    Registration closed