Public-registration training

GMP Basics

4.0 rating based on 143 ratings 4 rating based on 143 ratings.
Basic principles and overview of Good Manufacturing Practice (GMP) regulations

This training includes:

Upcoming edition starts 12-10-2023

GMP Basics

Basic principles and overview of Good Manufacturing Practice (GMP) regulations

4.0 rating based on 143 ratings 4 rating based on 143 ratings.

Duration undefined
143 students
Upcoming edition starts 12-10-2023

GMP Basics

What you will 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)

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Training language(s)

  • Dutch spoken language

Training description

The training

One-day training with the basic principles and an overview of Good Manufacturing Practice (GMP) regulations.

Gain insight into the basic principles of Good Manufacturing Practices (GMP) regulations in one day. We discuss the “what” and “why” of GMP and where to find these pharmaceutical regulations. In a number of lectures and workshops, the most important aspects of the preparation, packaging, analysis, release, storage and distribution of medicines under GMP conditions are discussed.

Target group

For employees who need a basic overview of the most important aspects of GMP, such as employees new to GMP or employees looking for a compact summary.

Learning objectives

  • 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

Results

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

Content

  • 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

Training program

11 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
LectureSub-lectures
Program - Day 1
LectureSub-lecturesDay
Learning objectives and course content

  • Round of introduction
  • 1
    GMP - Why do we do it?

  • The goal of the GMP's
  • 1
    Legislation of the pharmaceutical industry

  • Dutch laws and regulations
  • Europe, FDA, PIC/S, ICH
  • 1
    Pharmaceutical supply chain

  • 6 steps in the pharmaceutical supply chain
  • 1
    GMP Building Blocks

  • 1
    Qualitysystem

  • Quality & Quality system
  • Basic quality system elements
  • 1
    DOcumentation and Data Integrity

  • The goal of documentation
  • GMP documents
  • Raw Data and Good Documentation Practices
  • 1
    Workshop GMP

  • 1
    GMP in your own practice

  • Summarizing what has been learned
  • Draw up an action plan for your own practice
  • 1
    Quiz

  • Kahoot!
  • 1
    Evaluation & Closing

    1

    Training date(s)

    Start dateEnd dateVenuePriceStatus
    12-10-202312-10-2023Hotel Mitland 922 ex. VATOpen for registration
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    Lecturer(s)

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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

    12-10-2023

    Hotel Mitland

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    Preparation:
    Preparation required:Preparation requirements to be announced
    Preparation details:N/A
    Exam:
    Includes exam:No

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