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 in 2022

  • GAMP-2243 (25.+26. okt.)

    Choose your course:

    GAMP Guideline (the book)
    With ISPE's GAMP 5 guideWithout ISPE's GAMP 5 guide

    Your name *

    Your e-mail *

    Telephone number

    Company *

    Address

    ZIP code

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    Reference

    Comments

    Practical information

    Duration and address
    It is a 2 days course and is held at Comwell Roskilde: Vestre kirkevej 12, 4000 Roskilde, from 9am-16pm

    Feel free to contact us regarding courses in Jutland.

    Catering:

    Small breakfast

    Lunch

    Cake and Coffee/tea

    Price 

    The price for the course is DKK 10.500 (ex VAT) and is invoiced 14 days before the course. The price covers 2 days incl. material for the course and catering.

    If you are participating with a colleague, you will pay full price for the first registration and your colleague will receive a 15 % discount.

    ISPE GAMP5 guide

    We offer you the opportunity to purchase the ISPE GAMP5 guide for DKK 3.500,00 ex.VAT. (Normal price is DKK 4.200 if you are not a member of ISPE)

    Are you prevented from participating?

    By cancelation 0-14 days before the start of the course, you will be invoiced with 100%

    By cancelation 15-30 days before the start of the course, you will be invoiced with 50%

    Cancellation is free of charge if it is made more than 30 days before start of the course.

    If you are prevented due to illness, you have the opportunity to move your registration to another date or another course. You also have the option of sending a colleague instead.

    Cancellation made by Confirm

    At Confirm we strive to hold all announced courses, but due to the dynamics of our course, to few registrations may mean that we choose to cancel a course.

    Other courses or company-specific courses

    If you are interested in other courses or company-specific courses, you are always welcome to contact us at kursus@confirm.dk