Courses

All our courses are available in several formats to meet different needs. For example, we offer interactive e-learning, customised courses and instructor-led courses, both on-site and remotely (online).

Our ambition is to, at least, offer all courses as interactive e-learning within our eAcademy.

Aseptic production - coming 2023
principles of sterility and aseptic production
Combination products
Medical Device Regulation (MDR) for combination products
data integrity
securing data, meeting requirements and regulations
GAMP 5
quality assurance of computerised systems
GAMP 5 ED.2 - COMING 2023
quality assurance of computerised systems
GMP
Good Manufacturing Practice
ISO 13485
ISO 13485:2016 for Medical Devices
IVDR
an introduction to the regulatory framework for In Vitro Diagnostics
MDR
for manufacturers of medical devices
MDR/IVDR
for distributors & importers of Medtech & in vitro diagnostics
Medtech Software & MDR
software requirements in Medtech (MDSW, SaMD)
NEWS GAMP 5 ED.2
news in the second edition of GAMP 5
QA IT
quality assurance of computerised systems
Regulatory Affairs
current regulations in Europe and USA
System management
a practical guide and tools
Validation
an introduction to validation and qualification

WE MEET YOUR NEEDS

Let us help you ensure your professional development is of the highest quality. Whatever the area or scope, we can help you review your needs and ensure you are up to date with current regulations. Providing value today, tomorrow and into the future.