Public-registration training
GMP Basics
Basic principles and overview of Good Manufacturing Practice (GMP) regulations
GMP Basics
Look up the laws and regulations yourself
Translate various GMP rules to your own practice
Indicate requirements for working in a GMP environment (basic)
Dutch spoken language
The training
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
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.
| Lecture | Sub-lectures |
|---|
| Lecture | Sub-lectures | Day |
|---|---|---|
| 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 |
| Start date | End date | Venue | Price | Status |
|---|---|---|---|---|
| 12-10-2023 | 12-10-2023 | Hotel Mitland | € 922 ex. VAT | Open for registration |
Jolanda Tijmes
GMP Trainer
Jolanda Tijmes
To start your registration, first select the start date of the training, then fill in the form below.
Register now!
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| Times: | The course starts at 9:30 am and ends at 5:30 pm | ||||||
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€ 922 ex. VAT
Training certificate
Lunch buffet
11 Lectures
An in-house training is your best choice! We have more than 100 GxP in-house training courses on request.
