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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 English flag
  • 1 day and 8 hours in total

€ 795.00 ex. VAT

Registration ends in 245 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.

    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
    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.

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    Registration ends in 245 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?

    In-house training may be the best option for you! We have over 100 GxP in-house training courses.

    In-house training