Laboratory Management
GMP
During the training, you will gain insight into the basics of what GMP is and why it exists. Which authorities, requirements and regulations you must comply with. What a quality system is and its components. The importance of good documentation, deviation and change management. Risk and deviation management to understand how you can avoid deviations from GMP regulations. CONTENTS Basic principles [...]
System management
Effective systems management is crucial in regulated industries such as pharmaceuticals, where careful control and oversight of computerized systems is required. These systems, which are critical for everything from research and development to manufacturing and distribution of Pharma, must be managed to ensure consistent performance and compliance with strict regulatory standards. A robust system management helps to [...].
IVDR
The course is aimed at those who work with in vitro diagnostics and want to learn more about the new IVDR regulation. In May 2022, the old EU directive In Vitro Diagnostic Directive (IVDD) was replaced by the new regulation (2017/746) In Vitro Diagnostic Regulation (IVDR) to which the in vitro diagnostics industry is subject. This course gives you an introduction to the new [...].
Validation & qualification
Validation and qualification are a fundamental part of the pharmaceutical industry and other sectors of the life sciences industry. These processes ensure that equipment, method, process, premises and systems meet specified requirements and perform reliably for their intended use, meaning that they consistently deliver the expected product and function. Accuracy in these processes is essential [...].
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 [...]
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