Public-registration training

Good Distribution Practices (GDP) – also for the Responsible Person (classroom)

4.5 rating based on 408 ratings 4.5 rating based on 408 ratings.
PCS certification for the Responsible Person (RP) and Designated Person (Active Pharmaceutical Ingredient). GDP guidelines and Falsified Medicines.

This training includes:

Upcoming edition starts 07-11-2023
Register now!

Good Distribution Practices (GDP) – also for the Responsible Person (classroom)

PCS certification for the Responsible Person (RP) and Designated Person (Active Pharmaceutical Ingredient). GDP guidelines and Falsified Medicines.

4.5 rating based on 408 ratings 4.5 rating based on 408 ratings.

2 days in total
408 students
Upcoming edition starts 07-11-2023

Good Distribution Practices (GDP) – also for the Responsible Person (classroom)

What you will learn

Apply the basic quality systems to GDP-related topics

Carry out the responsibilities of the RP/DP in accordance with the regulations

Explain, implement and safeguard GDP legislation and regulations in your own organization

Tell us what you want to learn. Get free learning advice by clicking here!

Training language(s)

  • Dutch spoken language
  • English spoken eLearning

Training description

The training

1.5 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 2-day 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. Special attention is given to the role of the Responsible Person/Designated Person and recent changes in veterinary legislation.

With final exam for proven competence. This certificate is accepted by the Dutch regulatory authorities, in combination with relevant experience as a RP.

Target group

This course is intended for the (future) Responsible Person or Designated Person (API), Logistics manager (supervisor), Qualified Person, QA. HBO/WO level.

Learning objectives

  • Explain, implement and safeguard GDPR 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 regulations

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

Content

  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 (end 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
Setup of the training
Classroom training, two full days.

Training program

22 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.

eLearning
Program - Day 1
Program - Day 2
Program - Day 3
Program - eLearning Component
LectureSub-lectures
Program - Day 1
LectureSub-lecturesDay
Basics of distributing medicines

1
Quality Management

1
Personnel

1
Premises and equipment

1
Documentation

1
Operations

1
Complaints, returns, suspected falsified medicinal products and medicinal product recalls

1
Outsourced activities

1
Self-inspection

1
Transportation

1
Brokers

1
Program - Day 2
LectureSub-lecturesDay
Learning goals and course contents

2
Q&A eLearning

2
Validation and change in (cold chain) transport

2
Temperature mapping of the warehouse

2
Quality Management Review

2
GDP for veterinary products

2
IGJ (Dutch regulatory authority) expectations

2
Program - Day 3
LectureSub-lecturesDay
Deviation in temperature during transport

3
Overall risk assessment transport

3
GDP in your own practice

3
Closing note & exam

3

Training date(s)

Start dateEnd dateVenuePriceStatus
07-11-202308-11-2023Van der Valk Utrecht€ 1.729 ex. VATOpen for registration
Option 1 € 1.729 ex. VAT
Start date:

07-11-2023

End date:

08-11-2023

Venue to be announcedRegistration open
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Lecturer(s)

Karen Zimmermann
Karen Zimmermann
Senior GMP/GDP Trainer & Consultant

Karen Zimmermann is a GMP/GDP consultant and trainer at PCS. She has worked in several managerial Quality positions for Biotech and Pharmaceutical companies.
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René Maassen
René Maassen
Senior GMP/GDP Trainer & Consultant

René Maassen started his career at Solvay Pharmaceuticals, after being Head QA he became Senior Inspector GMP/GDP at the Dutch Healthcare Inspectorate (IGZ), he was director at PCS between 2003 and 2013.
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Riekert Bruinink
Riekert Bruinink
Senior GMP/GDP Consultant & Trainer

Riekert is a former Senior and Coordinating GMP- and GDP Inspector at the IGJ and member of EMA GDP-drafting group. Earlier he was also chairman of the GDP-working group for the pharmaceutical inspection coorperation scheme (PIC/s). He works as a consultant and trainer now in the field of GDP & GMP.
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Karen Zimmermann
René Maassen
Riekert Bruinink

Registration

To start your registration, first select the start date of the training, then fill in the form below.

Upon passing the exam, you will receive a Certificate of Competence. The exam is optional.

Participants
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General information

Learning form:Classroom
Times:The course starts at 9:30 am and ends at 5:30 pm
Venue(s):
Start dateVenueRegister

07-11-2023

Van der Valk Utrecht

Register

Preparation:
Preparation required:Preparation requirements to be announced
Preparation details:N/A
Exam:
Includes exam:Yes
Exam optional:Yes
Re-examination possible:Yes
Exam fee in course price:No
Examination fee for each exam attempt:250

€ 1.729 ex. VAT

Registration ends in 220 days.
Register now!
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The upcoming start date of this training is guaranteed.
This training includes: