Public-registration training
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.
Good Distribution Practices (GDP) – also for the Responsible Person (classroom)
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
Dutch spoken language
English spoken eLearning
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
- 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 (end 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
Setup of the trainingClassroom training, two full days.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.
Program - eLearning Component Lecture Sub-lectures Program - Day 1 Lecture Sub-lectures Day 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 Lecture Sub-lectures Day 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 Lecture Sub-lectures Day Deviation in temperature during transport 3 Overall risk assessment transport 3 GDP in your own practice 3 Closing note & exam 3 Start date End date Venue Price Status 07-11-2023 08-11-2023 Van der Valk Utrecht € 1.729 ex. VAT Open for registration Need training sooner?Click here to get personal training options.Karen Zimmermann
Senior GMP/GDP Trainer & Consultant
René Maassen
Senior GMP/GDP Trainer & Consultant
Riekert Bruinink
Senior GMP/GDP Consultant & Trainer
Karen Zimmermann
René Maassen
Riekert Bruinink
To start your registration, first select the start date of the training, then fill in the form below.
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Register for this training by clicking the button.Drag the table left or right to reveal all fields.Learning form: Classroom Times: The course starts at 9:30 am and ends at 5:30 pm Venue(s): Start date Venue Register 07-11-2023
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