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.
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
- 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.