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

4.5 rating based on 408 ratings. 408 students

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

Two day course on GDP guidelines and Falsified Medicines for human drugs and active ingredients (API), including changes in veterinary legislation!

4.5 rating based on 408 ratings. 408 students

GMP & GDP training for pharma & biotech

Language(s):

2 days in total

 1.729 ex. VAT

Registration ends in 210 days.

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

2-day course on GDP guidelines and Falsified Medicines for human drugs and active ingredients (API), including changes in veterinary legislation! Protection of the patient is the main task of wholesalers. This proven training provides an overview of the most important aspects in the GDP. This 2-day course on GDP guidelines and Falsified Medicines for human drugs and active ingredients (API), covers 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. An IGJ inspector is invited as one of the speakers. With optional final exam for proven competence. This certificate is accepted by IGJ, in combination with relevant experience as an 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 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 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.
Course content

LectureDay
Introduction to the course

1
Introduction to GDP

1
Chapter 1: Quality management to GDP

  • Quality systems
  • Workshop - deviation
1
Chapter 2: Personnel

  • The Responsible Person
  • The Responsible Person - Workshop
1
Chapter 3: Premises and Equipment

  • Validation
  • Validation of the warehouse
1
Chapter 4: Documentation

  • Documentation and data integrity
1
LectureDay
Introduction Day 2

2
Chapter 5: Activities

  • Workshop - activities
  • Workshop - supplier qualification
2
IGJ experiences

2
Chapter 6: Complaints, returns, suspected falsified drugs and drug recalls

  • Complaints, Returns & Recalls
2
Chapter 7: Outsourced activities

  • Outsourced activities
2
Chapter 8: Self-inspections

  • Self-inspections
2
Chapter 9: Transport

  • Overall risk assessment transport
2
Chapter 10: Specific provisions for intermediaries- Change Control

  • Intermediaries
2
GDP in your own practice

2
Closure and exam

2

Course dates

Start dateEnd dateVenuePriceStatus
12-11-202413-11-2024Van der Valk Breukelen 1.729 ex. VATRegister

Language

  • Dutch spoken language

General information

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

12-11-2024

Van der Valk Breukelen

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
Good Distribution Practices (GDP) – also for the Responsible Person (classroom) thumbnail
 1.729 ex. VAT

Registration ends in 210 days.

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

16 Lectures

Training 5 people or more?

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