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

4.5 rating based on 408 ratings. 408 students

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

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. 408 students

GMP & GDP training for pharma & biotech

Language(s):

1 day in total

 795 ex. VAT

Registration ends in 1 day.

The upcoming start date of this training is guaranteed.

What you'll 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

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 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
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 zooms in on the practical challenges and implications of drug distribution.
Course content

LectureDay
Basics of distributing medicines

- online/eLearning
1
Quality Management

- online/eLearning
1
Personnel

- online/eLearning
1
Premises and equipment

- online/eLearning
1
Documentation

- online/eLearning
1
Operations

- online/eLearning
1
Complaints, returns, suspected falsified medicinal products and medicinal product recalls

- online/eLearning
1
Outsourced activities

- online/eLearning
1
Self-inspection

- online/eLearning
1
Transportation

- online/eLearning
1
Brokers

- online/eLearning
1
LectureDay

Course dates

Start dateEnd dateVenuePriceStatus
28-05-202428-05-2024Van der Valk Breukelen 795 ex. VATRegister

Language

  • Dutch spoken language
  • English spoken eLearning

General information

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

28-05-2024

Van der Valk Breukelen

Register

Preparation:
Preparation required:Yes
Preparation details:eLearning 6-8 uur
Exam:
Includes exam:Yes
Exam optional:Yes
Re-examination possible:Yes
Exam fee in course price:No
Examination fee for each exam attempt:250
Good Distribution Practices (GDP) – also for the Responsible Person (blended) thumbnail
 795 ex. VAT

Registration ends in 1 day.

The upcoming start date of this training is guaranteed.

This training includes:

Lunch buffet

22 Lectures

Training 5 people or more?

In-house training may be your best choice! We have more than 100 GxP training courses on demand.