Hvorfor vælge Pharmakon ?
Lækre omgivelser med fantastisk mad og imødekommende service
Pædagogisk uddannede undervisere med praktisk erfaring fra life science
Varierende og involverende undervisning med eksempler fra hverdagen
14 december, 2023
4 november, 2024
Understand the impact of GMP in your work
You will get an insight into the GMP regulations. We will explore the requirements for the personnel, premises, and equipment as well as the many requirements to documentation. After the course, you will know what working according to GMP means and you understand the mindset it takes to produce safe medicinal products.
In just two days, you will get a basic knowledge of the basic EU-GMP regulations (EudraLex Vol. 4), and you will gain a foundation for understanding the GMP requirements in daily operations. After the course you will be able to participate in practical problem solving when it comes to interpretation of the GMP requirements in your work.
In this course we will explore topics such as quality, risk assessment and personnel behaviour. You will gain knowledge of what is required of premises and equipment to ensure the quality of medicinal products. You will also gain a thorough understanding of the expectations to GMP documentation.
You will be introduced to the GMP regulations through presentations and cases, where you will have the opportunity to discuss how the requirements should be interpreted in practice.
When you discuss the requirements with the other participants, you will gain a broader understanding of how the mindset of the personnel helps ensure compliance with GMP. In this way, you will get both a theoretical and practical basis for understanding and complying with the GMP requirements.
The days are a mix of presentations, exercises, and group work. Various GMP issues are discussed based on cases and experience.
- you are familiar with the GMP regulations and know how to comply with them in your work
- you can contribute to quality assurance in your company
- you will be aware of how the mindset and attitude towards documentation helps ensure the quality of medicinal products.
Din virksomheds udbytte
The company's benefits:
- your employee understands the importance of compliance with GMP regulations
- your employee helps ensure compliance with GMP
- your employee contributes to interpretation of the GMP requirements.
The course is intended for those who have limited GMP knowledge and in need of an overview of the GMP regulations, this course is for you, no matter whether you are supporter, manager or other in a production department, QC or QA.
The course is also relevant for those who already work in a GMP regulated facility and wants to gain insight into the regulations to better understand the implementation of the rules.
Pharmakon - et anerkendt uddannelses- og udviklingscenter for farmaceutisk praksis i Hillerød!
Vores navn er sammensat af "Pharma" og "kon". "Pharma" står for, at vi uddanner og udvikler dig, der arbejder med lægemidler. Vores fokus er kvalitet og medicinsikkerhed. "Kon" relaterer sig til vores konferencecenter, som er for alle – også dig,...