PCS-certification for the Responsible Person (RP) and Designated Person (API).
GMP & GDP training for pharma & biotech
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
Dates | Language | Price | Register |
---|---|---|---|
5/20/25 to 5/20/25 | Dutch spoken language (primary) | € 795.00 |
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If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,
Trainer
Experienced trainer, consultant, and Qualified Person with over 15 years of expertise in quality management within t...
Subject | Mode |
---|---|
Basics of distributing medicines
|
eLearning |
Quality Management
|
eLearning |
Personnel
|
eLearning |
Premises and Equipment
|
eLearning |
Documentation
|
eLearning |
Operations
|
eLearning |
Complaints, returns, suspected falsified medicinal products and medicinal product recalls
|
eLearning |
Outsourced Activities
|
eLearning |
Self-Inspection
|
eLearning |
Transportation
|
eLearning |
Brokers
|
eLearning |
Lecture | Day |
---|---|
Introduction and Learning Goals
|
1 |
Introduction to GDP
|
1 |
Workshop: Change in activities
|
1 |
Workshop: Qualification of suppliers
|
1 |
Quality Management Review in GDP
|
1 |
Workshop: Dealing with a temperature excursion
|
1 |
Expectations of the Dutch regulatory inspectorate (IGJ)
|
1 |
Workshop: Temperature mapping in the warehouse
|
1 |
Workshop: Validation and change in transport
|
1 |
Workshop: GDP in your own practice
|
1 |
Evaluation and closure
|
1 |
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.
4 out of 5 stars
Based on 165 reviews
5 star reviews
4 star reviews
3 star reviews
2 star reviews
1 star reviews
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
Download our training brochure for 2024 by clicking this link