Introduction to GAMP 5

This is how you can improve the quality and reduce the time consumption when developing computerized system.

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Hvem kan deltage?

The course is for engineers, technicians, chemists and others with or users of computerized systems in the pharma industry.
Automations and IT engineers.
Project engineers and managers.
QA employees and managers.
IT responsible.
Process technicians and chemists.
Machine builders and robot suppliers.

Kursusoversigt

Confirm Knowledge Center
Dansk / Engelsk

Forudsætninger for at deltage

There are now prerequisites for participants for the course apart from the interest in understanding the advantages of GAMP as a tool for suppliers of automated systems that must live up the current GMP rules.

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Introduction to GAMP 5

Good Automated Manufacturing Practice (GAMP) gives the possibility to follow a logic and systematic approach to categorization, documentation, and risk assessment of automated systems.

On this course you will achieve focused knowledge on how the methods of GAMP 5 can help you secure that the patient safety, product quality and data integrity live up to current expectations for your Computerized systems.

Information om kursus

Undervisningsform

Both instruction and course material will be in English on our English courses.

The course will consist of a mix between theoretical overview of the GAMP 5 guide and what it means in practice. We will use a ”practical project” as reference and use it for relevant examples and exercises.

To be able to make our course even better we will ask all participants to evaluate the course on the last day.

Kursets highlights

På kurset opnår du:

That you get a better understanding of GAMP 5 which will give better possibility to create your URS so it is specific, measurable, achievable, and prioritized so that you can avoid misunderstandings and misinterpretations.
That you know about software categorization and scaling.
That you have knowledge about which documents are necessary.
That you get useable methods for assessing and handling high, medium, low risks.
That you get knowledge about how to use your documentation.
That you get insight on you to get the most of your competencies and corporation.
How to build a common concept apparatus.
GAMP life cycle.

Kursusprogram

Introduction and presentation
GAMP background and purpose
Authorities and regulations
Other organisations in the business
GAMP 5 – Focus areas and news
GAMP 5 – Concept and introduction to life cycle
GAMP 5 – Project process with examples
Maintenance of compliance during operation
System execution

Efter kurset

You will have an overview of the current GMP rules and guidelines for development and verification of automated systems.
That you know where you can get inspiration and guidance for creation of relevant documents and which documents, and which phases you must undergo in planning, development and test of the systems.
That you know the issues in the different life cycles and at the different levels of complexity.
That you know how you must handle the risk according to patient safety, product quality and data integrity.
That you know how you must scale the specification and verification material.
That you know how you as a pharma manufacturer can implement requirements for sub suppliers in the overall validation activities and thereby can avoid double work.
That you know how you, as a sub supplier, can live up to the expectations of the pharma customers

Underviser på kurset

Jeppe Lunde Schmidt

Jeppe is working in our validation team. He works with and has validated many different types of IT and software controlling small equipment to larger complex systems. Furthermore, he has previously been working with validation of packaging equipment and serialization.

Udtalelser fra kursister

Kursist på Introduktion til GAMP 5
Virkelig god og fagligt stærk præsentation. Underviseren fandt det helt rigtige faglige niveau for gruppen og igangsatte gode opgaver og deraf afledte drøftelser. Og super med lille pause hver time.
Kursist på Introduktion til GAMP 5
Stor tak og meget ros til Katrine! Som underviser er du tilstedeværende, relevant, dygtig formidler og meget behagelig. Du formår at sætte dine erfaringer fra såvel undervisning som praksis i spil i den kontekst, vi stiller spørgsmålene i.
Kursist på Introduktion til GAMP 5
Jeg synes det at det var godt at mixe teorien og den praktiske del. Underviseren var super god til at forklare og super god til at trække eksempler frem, som understøttede teorien.
Kursist på Dataintegritet
Fordelen ved kurset er en hurtig og bearbejdet tilgang til ISPE-guiden.
Kursist på Dataintegritet
Det var et super godt kursus, der levede op til alle forventninger. Super god underviser 🙂
Kursist på Dataintegritet
Virkelig godt kursus… selv efter mange timer er man stadig med.. kursusleder kan fastholde fokus og interesse
Kursist på SattLine-programmering
A good structure of course material and balance between theoretical material and exercises. The theoretical parts gives food room for more in depth questions of interested.
Kursist på SattLine-programmering
Very motivated course-responsable, very pationate and patient.
Kursist på Dataintegritet
Godt med øvelser og quiz. Godt sted og lækker mad/forplejning.
Kursist på SattLine-programmering
Super underviser 👍😁

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