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 [...]
Validation & 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 [...]
GAMP5
Computerized systems are an essential part of the pharmaceutical and medical device industry, from research and development to clinical trials, manufacturing and distribution. Computerized systems used in the GxP environment must be reliable and adapted to their needs. This course provides an understanding of regulatory requirements and how to effectively quality assure computerized systems. Target audience The course [...]
Software for medical devices
The course starts with an overview of the current rules and regulations, starting with the Medical Device Regulation (MDR) with regard to software. We discuss software documentation in a technical file, including verification and validation, and you get an introduction to risk management and usability. In addition, the course covers the system life cycle of a Medical Device Software (MDSW), with a detailed [...].
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