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:
1 day and 8 hours in total

€ 795.00 ex. VAT

Registration ends in 178 days.

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

Start date	End date	Dates	Language	Venue	Price	Register
Tuesday, May 20, 2025	Tuesday, May 20, 2025	5/20/25 to 5/20/25	Dutch spoken language (primary)	Hotel Van Der Valk Breukelen	€ 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

Recent GDP inspection experiences
Changes in veterinary legislation, with emphasis on GDP for veterinary.
GDP legislation and regulations for end products (2013/C 343/01) and active raw materials (API) (2015/C 95/01) and Falsified Medicines Directive
Responsibilities of the Responsible Person (finished products) and Designated Person (API)
Supply Chain
Application of quality systems (incl. Change Control, Deviation Management, CAPA, Risk Management, Quality Management Review)
Documentation Requirements
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

Trainer

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

Program

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

eLearning platform

Our eLearning courses are hosted on our eLearning platform: Moodle. You can access our eLearning platform by navigating to: https://pcs-academy.site

In case the eLearning platform is unavailable at the time of purchase due to maintenance or server downtime you will be updated via email on restoration of the service.

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

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%
Language (upcoming edition):: Dutch spoken language (primary)

English spoken language (secondary)

English spoken eLearning

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)

Based on 165 reviews

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

2024

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

2024

4 out of 5 stars

Strong points (and why):

Goed tempo. Inhoudelijk goed. Veel interactie.

Bas de Zeeuw - Owner

2024

5 out of 5 stars

Strong points (and why):

De trainer!

Peter - Medical manager

2024

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

2024

4 out of 5 stars

Strong points (and why):

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

Anonymous - Anonymous

2024

4 out of 5 stars

Strong points (and why):

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

Rob Hart - QA/RA

2024

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

2024

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

2024

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

2024

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

2023

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

2023