Sharing knowledge and educating others is something we at Plantvision about. For us, it's about inspiring, developing, and discussing to gain new insights, while also highlighting highly topical issues. One such topic is undoubtedly GAMP 5 and, not least, the new version, GAMP 5 Second Edition. As experts in computerised systems, we simply know how to apply GAMP 5 in the best possible way. One reason why GAMP's guidelines have been so successful globally, and have become a kind of industry standard for both life science companies and suppliers in the life science sector, is that they have continuously reflected existing technological developments. The innovations and technological advances of recent years have led to the need to review and update the guidelines. With that, the need for new training in GAMP also grew.
"We at Plantvision very proud to present our new GAMP 5 Second Edition training course. It's an exciting time, and we are introducing a completely new learning experience. With over 3 hours of interactivity, including audio, text, and visual elements, we have developed a training course that really stands out. The way it is structured makes it truly unique,” says Anna-Lena Mann, Business Area Manager, Compliance.
Inom Life Science är pålitliga datoriserade system en avgörande faktor för framgång inom forskning, utveckling, tillverkning och distribution. Innanför ramarna för den reglerade verksamheten är tillförlitlighet och ändamålsenlighet absolut nödvändigt för att säkerställa patientsäkerhet för de produkter som finns på marknaden. Den som är verksam inom branschen måste därför förhålla sig till de strikta föreskrifter som myndigheterna kräver och det är anledningen till behovet för en utbildning.
First edition and second edition - what is the difference?
GAMP 5 Second Edition, launched in July 2022, has undergone significant development to match the continuous momentum and changes that characterize our industry. For example, the updated edition supports agile and iterative working methods. It also encourages the wider use of system and software tools, moving away from traditional paper-based documentation.
Like the previous version, GAMP 5 encourages a risk-based approach throughout the entire system lifecycle to ensure compliance with all regulatory requirements. Another significant improvement is that the new version clarifies the need for an initial risk assessment before the start of the project and continued continuous risk assessments throughout the project and system lifecycle. In addition, the Second Edition includes newly inserted guidance on the application of future technologies such as AI (Artificial Intelligence), Machine Learning, Blockchains and various cloud solutions.
New training platform supporting the interactive e-learning format
A new training platform has been created with different needs in mind. For example, if you have a leading role in a company, it should be possible to quickly get an overall picture of a topic and if you instead want, and need, to dig deeper and get a solid basic education in a specific area, there is something that suits you and your needs. Therefore, we have chosen to launch two course variants initially: 'Essentials of', which is a more compressed quick overview, and 'The Principals of', which is a more in-depth basic course.
The new interactive e-learning course 'Principles of GAMP 5 Ed.2' is tailored for those working with computerized systems in highly regulated activities, such as Life Science. The participant is first introduced to concepts such as data integrity, computerized systems and the V-model. Then they are guided through key concepts in GAMP, life cycle strategies and Quality Risk Management (QRM). All of this is presented in an engaging and interactive way using animations, relevant tests, quizzes and various learning activities. Great emphasis has been placed on meeting the 'Accessibility' requirements, and in this endeavor a range of solutions are therefore offered to the participant. For example, in addition to a guiding voice, there is also subtitling for those who prefer to absorb information through reading.
The core material of the course spans approximately three hours, but the actual time for completion can vary significantly depending on each individual's needs and pace of study. Participants have the option to pause the training at any time, providing flexibility and allowing for adaptation to each person's learning style. Whether the participant chooses to delve deeper into a topic, redo quizzes and modules to gain a better understanding, or fast-forward through familiar content, the unique learning journey can be tailored to the participant's needs and preferences.
As you know, GAMP 5 is crucial for life science companies as it offers a structured and standardized methodology to validate and ensure the reliability of their automated systems. It minimizes risks, complies with regulations and ensures product quality, which is critical for the industry with strict regulatory requirements and high safety standards.
It is important for us to create value, educate and inspire our customers and those who are part of our industry. This type of training is a new way of learning and the hope is that more people, regardless of their level of knowledge, will be able to understand and absorb GAMP 5 more easily. By sharing our knowledge and experience, as a leading competence company in the field, we believe that we can contribute to increasing knowledge levels and also to the development and future training in Life Science.
Want to know more? Contact Anna-Lena and Plantvision at plantvision
Or take a look at the Academy's website Academy | Plantvision