Good Distribution Practices (GDP) - including the Responsible Person (blended) | Pharma Training Course | PCS Academy

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

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

Practical GMP & GDP training for pharma and biotech professionals, taught by senior PCS consultants who advise manufacturers on real GMP issues every week.

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

€ 1235.00 ex. VAT

Registration ends in 238 days.

Reserve your seat

Awaiting approval? Pre-register now, no obligation Open
This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
  • Certificate of competence

    • What you will be able to do after this course

    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

    Upcoming dates: pick a seat

    Dates Language Price Register
    20/04/27 to 20/04/27 Dutch spoken language (primary) Dutch spoken language (primary) € 1235.00 Register for this date

    About this course

    What this course covers

    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.

    Who this course is for

    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,

    What you take back to work

    • 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.

    Programme

    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)
    • 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:
    To be announced.
    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

    Your trainers are practising PCS consultants. They spend most of their week helping pharma manufacturers respond to real GMP findings, audits and inspections, and bring that experience straight into the classroom.

    Francis Buiter avatar

    Francis Buiter

    Docent

    Francis Buiter is an experienced trainer, consultant and Qualified Person with more than 15 years...

    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 Premises Falsified Medicines Self Inspection

    Reviews (192)

    4 out of 5 stars

    Based on 192 reviews

    Review data

    5 star reviews

    34%

    4 star reviews

    60%

    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):

    De afwisseling tussen theorie en praktijk

    Ruben van Duijvenvoorde - Senior Consultant

    4 out of 5 stars

    Strong points (and why):

    Actief, interactief en aandacht voor behoefte voor pauzes/beweging

    Melanie - QA professional

    5 out of 5 stars

    Strong points (and why):

    Francis heeft een aanstekelijke manier van cursus geven en weet je ook voor de complexere onderwerpen goed te motiveren

    Roelof Kok - Bestuurder

    4 out of 5 stars

    Strong points (and why):

    Ze gaf ruimte voor discussie en hield goed in de gaten of iedereen nog genoeg energie had

    To be improved:

    In het verleden ook al GDP cursussen gevolgd en zie dezelfde casussen als een paar jaar geleden. Misschien leuk als er nieuwe worden toegevoegd

    Boris den Daas - QA manager/responsible person

    5 out of 5 stars

    Strong points (and why):

    De interactie en bezig zijn in de vorm van workshops

    Martine Van Der Plas - RP

    5 out of 5 stars

    Strong points (and why):

    Duidelijk, vlot en interactief met voldoende ruimte voor vragen en discussies

    Leendert Nijssen - Veiligheidsadviseur gevaarlijke stoffen

    5 out of 5 stars

    Strong points (and why):

    Willing to spend time to discuss topics in details

    To be improved:

    Put the case studies carousel on slides because now someone has to read them out

    Naaz - QP

    5 out of 5 stars

    Strong points (and why):

    Veel ruimte voor interactie, workshops boeiend

    Review:

    Fijne locatie, goed bereikbaar

    Kristie Spijker - Manager Quality Regulatory & SHE

    5 out of 5 stars

    Strong points (and why):

    Heldere informatie, actieve participatie

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Great training, diverse group. Valuable.

    Anonymous - Anonymous

    4 out of 5 stars

    Strong points (and why):

    Discussie en diversiteit aan interpretatie deelnemers

    Cees Broeren - Consultant

    5 out of 5 stars

    Strong points (and why):

    Trainers voice en speaking was very well to understand

    Kofi Amponsh - QA Officer

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    Registration ends in 238 days.

    Reserve your seat

    Awaiting manager approval? Pre-register now. It's free and without obligation. We'll hold your interest and follow up when you're ready to confirm. Pre-register, no obligation
    Difficulty:
    Beginner level Intermediate level
    This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
  • Certificate of competence
    • Training 5 or more people from the same site?

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