Quality assurance of computerized systems
QA has a critical role in assuring the quality of the company's computerized systems in GxP-regulated activities. This course provides an in-depth understanding of the life cycle of a computerized system with a focus on interpretation of regulations and guidelines such as 21 CFR Part 11, EudraLex Volume 4 Annex 11 and Annex 15 and GAMP5. The course gives you the tools to strategically manage [...].
MDR/IVDR för distributörer & importörer
Unik kurs i MDR/IVDR för dig som har rollen importör eller distributör. Kursinnehåll Efter att regelverken för medicintekniska produkter (Medical Device Regulation, MDR eller In Vitro Diagnostic Regulation, IVDR) infördes 2017 har företag som importerar och/eller distribuerar produkter fått utökade krav att uppfylla. Under denna kurs tittar vi specifikt på kraven för er som är […]
Karolinska
The Galderna
Permobil
Xbrane
Elekta
The Swedish eHealth Agency
AstraZeneca
Validation and qualification
During the training, you will gain insight into the basic tools and knowledge for effective validation and qualification through a risk-based approach for both process equipment and computerized systems in Life Science. Through a combination of theory and practical exercises, we explore how you can apply a risk-based approach to both prevent and manage potential nonconformities [...]
Regulatory Affairs
Our Regulatory Affairs services Technical documentation Technical documentation is the backbone of your product development and enables future market introduction. We build solutions that are tailored to your intended use, risk class and business objectives and that also free up time and reduce the risk of costly rework. Clinical evaluation Clinical evaluations are not only a requirement in
Quality assurance & QMS
Våra tjänster inom Kvalitetssäkring Kvalitetslednings- system Att skapa ett kvalitetssystem som uppfyller regelverk och standarder är relativt lätt. Att däremot lyckas ta fram ett kvalitetssystem som både är compliant och anpassat utifrån er verksamhet, som blir ett stöd istället för ett hinder, det är allt annat än trivialt. Med rätt kompetens och stöd blir både […]
Validation
Our services in Validation Validation of computerized systems Validating that systems are reliable and comply with regulations and guidelines (such as GAMP) is crucial to meet both regulatory requirements and business needs. We have deep and long-standing expertise in computerized systems validation (CSV), and have been offering training in the field for many years. Validation [...]
Requirements management
Våra tjänster inom Kravhantering Krav- specifikation Rätt krav i kravspecifikationen är grunden för ett framgångsrikt projekt. Vi hjälper dig att samla in, formulera och strukturera krav så att de går att testa, spåra och leva upp till. Samtidigt som vi har koll på underliggande regelverk. Leverantörs-bedömningar Det är viktigt att välja rätt leverantör utifrån krav […]
Compliance Life Science
QA IT Copy
During the course, you will deepen your knowledge of how to effectively quality assure computerized systems, from acquisition to decommissioning. The course covers areas such as requirements definition, supplier assessment, qualification and validation of systems. An in-depth understanding of relevant regulations is necessary to ensure that systems meet the stringent requirements of a GxP-regulated business. Risk management, systems management, change management and [...].
MDR
Gain an understanding of MDR and its impact on medical device manufacturing. During the training, you will gain insight into the MDR regulatory framework, the CE marking process and the requirements for quality management systems according to ISO 13485. You will have the opportunity to discuss and do exercises, which can help you understand how you can implement the regulations in your business to not only [...]
MDR & IVDR
Learn the basics of the MDR and IVDR regulations! During the training, you will gain insight into how the regulations affect you as an importer or distributor. We combine theoretical basics on the roles and responsibilities of economic operators with practical exercises where you get to apply your new knowledge. You will also have the opportunity to discuss and do exercises, providing a [...]
GAMP5
During the training, you will gain insight into the regulatory requirements and how computerized systems should be quality assured in an effective way. You will get an overview of the content of GAMP 5 with a focus from a perspective for you as a requirement setter, customer, supplier and manager of system solutions, for GxP and MDR-regulated activities. Review of international standards such as EU [...]
MDR & IVDR
Learn the basics of the MDR and IVDR regulations! During the training, you will gain insight into how the regulations affect you as an importer or distributor. We combine theoretical basics on the roles and responsibilities of economic operators with practical exercises where you get to apply your new knowledge. You will also have the opportunity to discuss and do exercises, providing a [...]