Introduction to GAMP 5

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

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.

Course highlights

In introduction to GAMP 5 the following will be emphasized:

  • 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.

Furthermore, you will get knowledge about:

  • How to build a common concept apparatus
  • GAMP life cycle
  • GAMP life cycle

After the course:

  • 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

Course programme

  • 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

Form of instruction

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 us it fore 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.

Who can participate?

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

Prerequisites
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.

Instructor 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.

Registration and practical information

Registration

Below you can choose the course you want to attend and fill in your registration. You will receive a confirmation within a few days. We look forward to welcoming you.

Introduction to GAMP5 in english

  • 24.-25.january 2023

 

Practical Information

Duration and address
It is a 2 days course and is held at Confirm Knowledge Center
Havnevej 1 1tv, 4000 Roskilde, from 9am-16pm

Catering
Small breakfast
Lunch
Cake and Coffee/tea

Terms

Price
The price for the course is DKK 10.500 (ex VAT) and covers 2 days of teaching incl. course material and catering.

Payment and payment types

The payment is debited from the payment card 14 days before the start of the course. We accept Visa Dankort, Visa and Mastercard.

 

Cancellation

Cancellations up to 30 days before the start of the course can be made without charge. In case of cancellation after 30 days and within 14 days before the start of the course, 50% of the price is paid. Cancellation later than 15 days before the start of the course, the full amount is paid.

Cancellations must be notified to kursus@confirm.dk.

Possible cancellation

Should Confirm be forced to cancel the party, the full amount will be refunded.

 

Contact etc.

The course is offered by Confirm A/S, CVR no. 26039258, Havnevej 7, 2. tv., 4000 Roskilde. We can be contacted on tel. 7070 7686 or kursus@confirm.dk.

 

Storage of personal data

See Confirm’s personal data policy: her .