Good Distribution Practices (GDP) - including the Responsible Person (blended)
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Good Distribution Practices (GDP) - including the Responsible Person (blended)

PCS-certification for the Responsible Person (RP) and Designated Person (API).

GMP & GDP training for pharma & biotech

  • Language:
    Dutch flag
  • 1 day and 8 hours in total

€ 795.00 ex. VAT

Registration ends in 191 days.

Register now!

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

    Explain, implement and safeguard GDP legislation and regulations in your own organization

    Applying the basic quality systems to GDP-related topics

    Carry out the RP/DP's responsibilities in accordance with the GDP regulations

    Training Dates

    Dates Language Price Register
    5/20/25 to 5/20/25 Dutch spoken language (primary) € 795.00 Register

    Description

    The Training

    One day blended course on GDP guidelines and Falsified Medicines for human and veterinary medicines and active ingredients (API). Including the recent changes in veterinary legislation!
     
    Patient protection is the main task of wholesalers. This proven training provides an overview of the most important aspects in GDP.
     
    This course on GDP guidelines and Falsified Medicines for human medicines and active raw materials (API), discusses current laws and regulations and what this means in practice. With final exam for proven competence.
     
    Special attention is given to the role of the Responsible Person/Designated Person and recent changes in veterinary legislation.
     
    The certificate of attendance is accepted by the Dutch regulatory authorities, in combination with relevant experience as a RP.

    Target Audience

    This course is intended for the (future) Responsible Person or Designated Person (API), Logistics manager (supervisor), Qualified Person, QA. HBO/WO level.

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

    Results

    • Interpret and translate GDPR into practice
    • Insight into "gaps" within your own organization
    • GDP knowledge as required for the Responsible Person
    • Know and implement the new veterinary GDP requirements

    Contents

    1. Recent GDP inspection experiences
    2. Changes in veterinary legislation, with emphasis on GDP for veterinary.
    3. GDP legislation and regulations for end products (2013/C 343/01) and active raw materials (API) (2015/C 95/01) and Falsified Medicines Directive
    4. Responsibilities of the Responsible Person (finished products) and Designated Person (API)
    5. Supply Chain
    6. Application of quality systems (incl. Change Control, Deviation Management, CAPA, Risk Management, Quality Management Review)
    7. Documentation Requirements
    8. Complaints, returns & recall
    Set-up of the training
     
    Take the basic theory online in advance at a location and time of your choosing (6-8 hours), followed by a one-day on-site training that focuses on the practical challenges and implications of drug distribution.

    Lecturer

    Francis Buiter avatar

    Francis Buiter

    Trainer

    Experienced trainer, consultant, and Qualified Person with over 15 years of expertise in quality management within t...

    Program

    Practical Information

    Difficulty / Level:
    Group discounts:
    • 2 participants - 5%
    • 3 participants - 10%
    • 4 participants - 15%
    • 4 participants - 20%
    • 6+ participants - 25%
    Language (upcoming edition):
    • nl flag Dutch spoken language (primary)
    • en flag English spoken language (secondary)
    • en flag English spoken eLearning
    • nl flag eLearning has Dutch subtitles
    • Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
    Learning form:
    Blended
    Times:
    Starts at 09:30 and ends at 17:30
    Requires preparation:
    Yes.

    You will follow an eLearning course lasting between 6 to 8 hours (depending on how quickly you want or can follow it). The eLearning will be sent to you in a timely manner.

    Includes exam:
    Yes.
    Exam price:
    €250.00 ex. VAT per participant.

    Reviews (165)

    4 out of 5 stars

    Based on 165 reviews

    Review data

    5 star reviews

    31%

    4 star reviews

    62%

    3 star reviews

    7%

    2 star reviews

    0%

    1 star reviews

    0%

    Reviews prior to 2017 were paper-based and are not included below.

    5 out of 5 stars

    Strong points (and why):

    De spreker brengt de inhoud als dialoog. Ze let ook goed op dat iedereen mee komt.

    Review:

    Hooguit kort de looproute vanaf station aanstippen (omdraaien als je langs Ed Kroket loopt).

    Martijn Kooij - QP

    5 out of 5 stars

    Strong points (and why):

    Interactief en met goede casussen.

    Review:

    Meer proef examenvragen oefenen? Dank voor de tijd en duidelijke uitleg.

    Erdem Duman - QA officer

    4 out of 5 stars

    Strong points (and why):

    Goed tempo. Inhoudelijk goed. Veel interactie.

    Bas de Zeeuw - Owner

    5 out of 5 stars

    Strong points (and why):

    De trainer!

    Peter - Medical manager

    4 out of 5 stars

    Strong points (and why):

    Het interactieve in een kleine groep was prettig, zo kwam de discussie op gang en ga je dieper op de stof in.

    Review:

    Ik persoonlijk vond het deel omtrent en door iemand van de IGJ nogal droge stof met weinig interactie.

    Boris - QA officer

    4 out of 5 stars

    Strong points (and why):

    Door de elearning vooraf kon de live training meer op details ingaan.

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Een mooie mix van theorie en toepassing dmv casussen e.d.

    Rob Hart - QA/RA

    5 out of 5 stars

    Strong points (and why):

    zoals aangegeven in de bovenstaande score erg leuk en goed.

    mandy de Kwant - Quality Operations Specialist

    5 out of 5 stars

    Strong points (and why):

    Veel theoretische info in de e-modules en interessante case voorbeelden tijdens de live dag. Snelle reacties per mail op vragen!

    Nadjieba Joemman - QA Associate

    5 out of 5 stars

    Strong points (and why):

    Heldere goede uitleg, diepgang.

    To be improved:

    Nope

    Review:

    De trainer behouden :)

    Maurice Lousberg - Logistiek Manager

    5 out of 5 stars

    Strong points (and why):

    Verantwoordelijkheden RP

    Review:

    Belangrijk om te weten waarvoor je verantwoordelijk bent. Aan te raden voor mede RP's.

    Helma Frasa - RP

    5 out of 5 stars

    Strong points (and why):

    Algemene regels omtrent GDP. Opslag. Waar welke documentatie te vinden. Aanrader voor QA, logistiek medewerkers, expeditie, management.

    Review:

    Ik heb gemerkt dat een basis GDP wel handig is om de cursus te volgen. Zelf heb ik niet veel ervaring in GDP, klein beetje GMP. Soms lastig te volgen of gaat te snel.

    Irene Loppersum - operationeel manager

    training image

    € 795.00 ex. VAT

    Registration ends in 191 days.

    Register now!