GMP Basics

4 rating based on 143 ratings. 143 students

GMP Basics

Basisprincipes en overzicht van Good Manufacturing Practice (GMP) regelgeving

4 rating based on 143 ratings. 143 students

GMP & GDP training for pharma & biotech


Duration undefined

 922 ex. VAT

Registration ends in 16 days.

The upcoming start date of this training is guaranteed.

What you'll learn

Look up the laws and regulations yourself

Translate various GMP rules to your own practice

Indicate requirements for working in a GMP environment (basic)


The training

One-day training with the basic principles and an overview of Good Manufacturing Practice (GMP) regulations.
Most GMP training courses are aimed at operators, analysts and people working within the quality department and are therefore less suitable for people from the periphery. But employees of pharmaceutical companies whose activities are more indirectly related to GMP must also have knowledge of GMP. Think, for example, of employees of purchasing, sales, production planning, human resources, documentation and secretaries. Despite the fact that they do not produce or analyze medicines themselves, their involvement in the production of high-quality medicines or in maintaining a well-functioning quality system is certainly important. Ultimately, they are often a direct or indirect player in one or more quality systems and their activities contribute to the proper functioning of the company. For this reason, PCS has developed a 1-day course that focuses on those parts that provide a good general understanding of what is involved in the development, production and analysis of medicines.

Target group

This training is intended for employees of pharmaceutical companies who are more involved with GMP in the background. This includes employees of the purchasing, sales, finance, marketing, logistics, documentation or human resources departments, as well as planners and secretaries.

Learning objectives

  • Have a basic understanding of the contents and the importance of the GMP regulations
  • Understand how a Quality Management System (QMS) is set-up in a GMP environment
  • Indicate requirements for working in a GMP environment (basic)
  • Being able to look up the laws and regulations yourself
  • Translating different GMP rules into your own practice


  • Understanding the main responsibilities of a pharmaceutical manufacturer
  • Awareness of the importance of GMP
  • Basic understanding of GMP requirements


  • Why GMP?
  • Current EU rules and practical implications
  • Insight into which systems are needed
  • Key Quality System Elements (incl. Change Control, Deviations, CAPAs and Risk Management)
  • Documentation and Data Integrity
  • GMP in your own practice
Course content

Learning objectives and course content

  • Round of introduction
GMP - Why do we do it?

  • The goal of the GMP's
Legislation of the pharmaceutical industry

  • Dutch laws and regulations
  • Europe, FDA, PIC/S, ICH
Pharmaceutical supply chain

  • 6 steps in the pharmaceutical supply chain
GMP Building Blocks


  • Quality & Quality system
  • Basic quality system elements
DOcumentation and Data Integrity

  • The goal of documentation
  • GMP documents
  • Raw Data and Good Documentation Practices
Workshop GMP

GMP in your own practice

  • Summarizing what has been learned
  • Draw up an action plan for your own practice

  • Kahoot!
Evaluation & Closing


Course dates

Start dateEnd dateVenuePriceStatus
12-10-202312-10-2023PCS Training Room 922 ex. VATRegister


  • Dutch spoken language

General information

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


PCS Training Room


Preparation required:Preparation requirements to be announced
Preparation details:N/A
Includes exam:No
GMP Basics thumbnail
 922 ex. VAT

Registration ends in 16 days.

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

11 Lectures

Training 5 people or more?

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