Quality Management – The Role of the Qualified Person
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Quality Management – The Role of the Qualified Person

Quality Management - Exploring the role of the Qualified Person

  • Based on 682 participants

GMP & GDP training for pharma & biotech

  • Language:
    English flag
  • 5 days in total

0 ex. VAT

Registration is closed.

Registration closed

This training contains:
  • Lunch
  • Course dinner
  • Digital copy of materials
  • Training certificate
  • Certificate of competence

    • What you will learn

    Identify elements of applicable GMP regulations and GMP expectations across the product life-cycle

    Understand current regulatory developments and their business impact,

    E.g., new regulations, the Falsified Medicines Directive (serialization) and significant issues that may impact the business

    (Data integrity, drug shortages and supply chain integrity),

    Apply the basic principles of quality management from a regulatory and business perspective

    Training Dates

    Dates Language Price Register
    4/8/25 to 5/15/25 English spoken language (primary) € 3225.00 Closed

    Blok A starts 4/8/25 and ends 4/9/25.

    what does this mean?

    Blok B starts 5/13/25 and ends 5/15/25.

    Description

    The Training

    This training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical and biotechnological industries and hospitals to safeguard the quality of their products. There will be a focus on the role and responsibilities of the Qualified Person (QP) as well as on legislation, guidelines and best practices. We will also discuss common challenges a QP encounters in his/her day-to-day activities. You will participate in a team to work out a case study in the period between the first and second training sessions.
     
    The Qualified Person watches over product quality while taking patient safety and product availability into account. This requires an in-depth understanding of the role and responsibilities of the Qualified Person. This training is divided into two parts:
    1. April 8 to April 9 2025,
    2. May 13 to May 15 2024.

    The total duration is five days.

    This training is of an advanced level. A basic level of GMP knowledge is required to attend this training. The training program is not designed to address the basic theoretical principles of GMP. The practical implication of the GMP principles, real-life cases and the role of the QP are the focus of this training. A Qualified Person is expected to be aware of a number of pre-approval elements; an overview of the product life-cycle, Toxicology and the Registration Dossier. The training is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies. The self-study prior to the module consists of reading and following eLearnings.

    Target Audience

    Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and CRO’s, Hospital pharmacists and Postgraduate students.

    The training is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control and Quality Assurance 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 training is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).

    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

     •    Thorough understanding of the specific regulatory duties and responsibilities of senior management, functional leaders, the Qualified Person and Responsible Person.
    •    Insight into the integrated approach on Quality Management to safeguard product quality.
    Tools to realize and improve, pro-actively and on an ongoing basis, effective quality management across the various stages of the product lifecycle.

    Contents

    • Quality Management as a good business practice across the product life-cycle
    • Basic Principles of Quality Management
    • The specific regulatory role and responsibility of the Qualified Person
    • Quality Management System elements: deviation management, change control, RCA, validation & qualification, training and qualification of personnel, customer complaint management, audit systems and third-party operations
    • Similarities and differences between local (small) organizations and global (large) organizations
    • Current regulatory developments and (IGJ) inspection highlights
    • The critical impact of culture and behavior on compliance
    • Trending, Management Reviews and QP involvement
    • The Registration Dossier: it’s development, life-cycle and the role of the QP
    • Toxicology, including Health Based Exposure Limits
    • From development to clinical to commercial
    • QP experiences
    • Industry, hospital environment, international setting
    • Real-life challenges such as QP declarations and drug shortage prevention
    • Real-life case studies
    • Including participation in a team to work out a case study in the period between the first and second training sessions.

    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
    		Next edition: 11/18/25 3d € 2590.00
    Quality Management - the Role of the Qualified Person (Current Module)
    		No dates planned 5d 0
    Quality Management in Drug Development
    		Next edition: 6/3/25 2d € 2280.00

    Practical Information

    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):
    • 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. You will also follow a 45-minute eLearning course. The eLearning will be sent to you in a timely fashion.

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

    For Block A, the dinner is scheduled on day 1. For Block B, it is on day 2.

    Lecturers

    Jolanda Muurman avatar

    Jolanda Muurman

    Trainer

    Anna Myra Koopmans avatar

    Anna Myra Koopmans

    Trainer

    Christine Mitchell avatar

    Christine Mitchell

    Trainer

    Tags

    Change Control GMP GDP EudraLex Volume IV Medicines Act Deviations Quality Assurance QC Calibration Validation Qualification CSV Quality Culture Packaging Sampling Batch Review Manufacturing Distribution CCS Sterile Aseptic Writing Procedures OOS Biopharmaceutical Qualified Person Data Integrity GLP CAPA Quality Awareness Complaints QP Skills QP Declaration API Excipients ICH Q9 MAH Registration Dossier R&D Toxicology HBEL Pharmacovigilance IMP Risk Management Training Data Integrity IGJ Quality Metrics

    Reviews (69)

    4 out of 5 stars

    Based on 69 reviews

    Review data

    5 star reviews

    35%

    4 star reviews

    55%

    3 star reviews

    9%

    2 star reviews

    1%

    1 star reviews

    0%

    4 out of 5 stars

    Strong points (and why):

    The workshops

    Review:

    For the morning session try a bit more interactive parts

    Marten Hansen - Head LCT

    4 out of 5 stars

    Strong points (and why):

    The tempo was good and there was nice contrast between lectures and workshops

    Review:

    I thought Eric had a bit to much theactrics, which was fun but could be a bit less

    Lex van Midden - QA Intern

    4 out of 5 stars

    Strong points (and why):

    Effort to keep engagement from the participants, great preparation

    Review:

    For the team activities it would be easier if handouts are provided since the problem to be discussed and the questions were in different slides.

    Natalia - QP

    5 out of 5 stars

    Strong points (and why):

    RASCi chart

    Review:

    All training were excellent and well demonstrated. Training program was well arranged and topics are covered appropriately.

    Sunil Patil - Head QA

    5 out of 5 stars

    Strong points (and why):

    The different trainers with different experices and backgrounds

    To be improved:

    None

    Review:

    Schedule more time for discussions or cases, not both as these where difficult to fit in the timeframe The presentation by Tjitske was sometimes a bit hard to follow and jumped around on topics.

    Barry van den Berg - Student University Leiden

    4 out of 5 stars

    Strong points (and why):

    Interactive parts with examples from practice

    Review:

    Time management could be better so presentations are not shortened by time, furthermore time was monitored very well.

    rudolf kloppenburg - Quality manager

    4 out of 5 stars

    Strong points (and why):

    Good variation in presentation and workshop. Good amount of attendants to have discussions

    Review:

    Day 2 after the lunch was pretty heavy stuff, maybe some more activity then! For hospital oharmacy it would be great to hear challenges instead of what is manufactured

    Sofieke - Hospital pharmacist

    4 out of 5 stars

    Strong points (and why):

    Various workshops

    Review:

    Sometimes people were difficult to hear, soft voice

    Charlotte - QP / Ra

    4 out of 5 stars

    Strong points (and why):

    The active case studies

    Review:

    Subject of tjitske was less of interest to me. Would have wanted some examples.

    Yolanda - Hoofd QA

    4 out of 5 stars

    Strong points (and why):

    - Toevoeging van workshops was leuk en verdiepend - Afwisseling van de onderwerpen was goed - Trainers met veel kennis van de inhoud - Open en prettige sfeer; mogelijkheid om alle mogelijke vragen te stellen - Mooie locatie

    Review:

    - Leuk als overal workshops/study cases worden ingebouwd met focus op de rol van de QP: wat zou jij doen? (grey area's) - Het zou prettig zijn als er iets meer ruimte was om tussendoor even naar buiten te gaan; het was wel erg lang stil zitten. Wat dat betreft helpt de locatie (tussen snelweg en spoor) ook niet helemaal mee. Overigens op zich wel heel mooie locatie hoor. - Het Engels van diverse sprekers was wel voor verbetering vatbaar. Jammer als dit ten koste gaat van de diepgang. - Stuk over legislation zou ik iets anders opzetten; was nu wat lastiger te volgen. Duidelijk zou moeten worden wat er als QP van je verwacht wordt en waar dat te vinden is. Als je daarmee begint, zou je ook al een doorkijkje kunnen geven naar onderwerpen die later behandeld worden zoals bijvoorbeeld de QP declaration. Dan krijgt de dag ook al meteen meer samenhang. Anna-Myra Koopmans vond ik heel prettig in de omgang en kwam ook heel kundig over. Presentatie mag hier en daar best wat duidelijker en overtuigender gebracht worden. Ik vond dat bij Jolanda Muurman een hele mooie balans was tussen even kort de inhoud herhalen en dan een verdiepende workshop. Hier kreeg ik energie van. Het stuk over validatie was echt te lang. Jammer dat een presentatie dan afgekapt moet worden. Een workshop was hier ook leuk geweest. Eric van Wensveen deed veel moeite om het verhaal aanspreekbaar te maken en heeft heel veel kennis en interessante verhalen, maar op een gegeven moment werd het ook iets te veel een toneelstukje (OOS) en dat vond ik tekort doen aan de inhoud. Het werd er een beetje ongemakkelijk van. Het verhaal van Tjitske Veenbaas ging erg in op de verschillen tussen industrie en ziekenhuis, maar ik zou ook willen benadrukken dat het voorraad stuk wel steeds meer naar de industrie toe groeit. Het stuk over ATMP zou ook wat uitgebouwd kunnen worden. Misschien is het ook een idee om een QA/QP uit een ziekenhuis hierover iets te laten vertellen. Tjitske ken ik goed en heeft natuurlijk veel kennis, maar dan met name over het productie en individuele stuk. Desiree Vendrig zou wat meer inleiding kunnen geven aan wat een QP declaration nu precies is. Verder wel heel prettig kundig verhaal. Ik heb wat meer moeite genomen voor de evaluatie omdat het voor jullie de eerste keer was en actief vroegen hoe het verbeterd kan worden. Mijn bedoeling is om jullie daarmee te helpen en niet alleen om te bekritiseren. Ik heb echt een leuke en leerzame twee dagen gehad en ben benieuwd naar de volgende drie.

    Anonymous - Anonymous

    4 out of 5 stars

    Anonymous - Anonymous

    4 out of 5 stars

    Anonymous - Anonymous

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    Registration is closed.

    Registration closed

    Difficulty:
    Intermediate level Professional level
    This training contains:
  • Lunch
  • Course dinner
  • Digital copy of materials
  • Training certificate
  • Certificate of competence
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