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

€ 849.00 ex. VAT

Registration ends in 215 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
    6/2/26 to 6/2/26 Dutch spoken language (primary) € 849.00 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 in pharmaceutical logistics.

    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.

    Program

    Practical Information

    Difficulty / Level:
    Beginner level and Intermediate 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):
    • 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 09:00 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.

    Lecturer

    Francis Buiter avatar

    Francis Buiter

    Trainer

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

    Tags

    Change Control GDP EudraLex Volume IV Medicines Act Deviations Quality Assurance Calibration Validation Qualification Quality Culture Distribution Responsible Person ALCOA Raw Data CAPA Rootcause Analysis QMS Designated Person Risk Assessment Temperature Mapping Incoming Goods Storage Transportation Cold Chain Quality Awareness Complaints Personnel Training Facility Equipment Documentation GDocP Outsourcing Recall Returns IGJ Premises Falsified Medicines Self Inspection

    Reviews (175)

    4 out of 5 stars

    Based on 175 reviews

    Review data

    5 star reviews

    31%

    4 star reviews

    63%

    3 star reviews

    6%

    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):

    Open sfeer, leerzaam en leuke workshops

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Interactief

    Review:

    Ga zo door

    Anonymous - Head of QEHS

    4 out of 5 stars

    Strong points (and why):

    Praktische vraagstukken

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Alles was goed uitgelegd

    Review:

    E-Learning mag iets korter

    Sonja - Logistiek coördinator

    4 out of 5 stars

    Strong points (and why):

    Dat er zoveel onderwerpen werden besproken en workshops

    Anonymous - Quality associate

    4 out of 5 stars

    Strong points (and why):

    Goede keuzen van onderwerpen en casuïstiek, relevante en juiste duur en diepgang.

    Review:

    Toch enige voorbeelden bijd e elearning doen. Dat helpt echt bij het begrip.

    Anonymous - GDP inspecteur

    5 out of 5 stars

    Strong points (and why):

    Enthousiaste trainer met veel kennis. Interactief door de workshops. IGJ inspecteur is een echte toevoeging.

    Anonymous - QA Officer

    4 out of 5 stars

    Strong points (and why):

    Interactieve cases

    Review:

    Niet dat ik het voor nu kan bedenken.

    Anonymous - QA Officer

    4 out of 5 stars

    Strong points (and why):

    Duidelijk

    Anonymous - Anonymous

    5 out of 5 stars

    Strong points (and why):

    GDP naar het praktijk brengen en duidelijkheid geven voor sommige interpretaties van GDP

    Review:

    Meer tijd voor de casussen, misschien minder casussen maar meer tijd voor discussies voor Graag IGJ weer bij de volgende training. Dat was super waardevol

    Keti Paspaleva - QP/RP

    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

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    Registration ends in 215 days.

    Register now!

    Difficulty:
    Beginner level Intermediate level
    This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
  • Certificate of competence
    • Training 5 persons or more?

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