data integrity
In regulated activities such as the pharmaceutical industry, data integrity is fundamental to ensuring that all computerized systems handle data correctly and reliably. This means maintaining and protecting data throughout its lifecycle - from collection to archiving - to guarantee that the information is complete, accurate and accessible to authorized parties. Complying with GxP regulations does not require [...]
MDR & IVDR
Companies producing medical devices, in vitro diagnostics and laboratory medical devices are subject to the Medical Device Regulation (MDR) and/or the In Vitro Diagnostic Regulation (IVDR). Regulations place high demands on all economic operators in the sector, including distributors and importers. It is crucial for these actors to have a thorough understanding of their obligations and responsibilities. With knowledge [...]
MDR & IVDR
An introduction to MDR & IVDR especially for those who have the role of importers or distributors The medical device and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). This course provides you with insight and knowledge of, among other things, definitions and the requirements imposed on the economic operators, [...].
MDR
All medical devices that are placed on the European market must be CE marked as proof that the product complies with the applicable legal requirements. During this training you will get an overview of the Medical Device Regulation (MDR), the process of CE marking and insight into the quality management system for medical devices (according to ISO 13485). After the course you will have insight and knowledge of [...].
GAMP 5
Computerized systems are an important part of the Life Science industry and play a critical role from research and development to clinical trials, manufacturing and distribution. Systems used in GxP-regulated environments must be reliable and carefully customized to meet the specific needs and requirements. Good Automated Manufacturing Practice (GAMP) is a well-established