Online trainings


As for all our training courses, web-Seminars are given by our experts and you can ask your questions via chat or during the question and answer sessions.

After your registration you will receive your access data for the web-Seminar. To participate, you will need a computer/laptop with internet connection and speakers, and ideally a microphone in order to actively participate in the training course. For optimal sound quality we recommend a headset. The training material can be downloaded after the web-Seminar. You will receive a certificate of participation after the training.

Our digital training programme is still under construction. So please check our website regularly to keep yourself up to date about the available dates.

This first IVDR e-Learning session is focussed on how to kick-off the implementation planning for the IVDR transition. Based on an exemplary transition plan, priorites as well as work packages...
This IVDR e-Learning session is focussed on how the REACH regulation on chemicals impacts your IVDs. The session will provide you an idea on how to monitor critical product components and what to do when your IVD contains substances of concern or...
This IVDR e-Learning session is focussed on potential re-classifications of your IVDs and the respective impact on your conformity assessment procedures. Based on practical examples, we walk you through the actions and steps to be taken...
This e-Learning session is focused on the impact of the IVDR on economic operators such as manufacturers, importers and distributors. It helps you understand how obligations were shifted and provides answers to the most commonly asked questions...
This e-Learning session is focused on how to analyse data to establish and/or verify of the scientific validity, the analytical performance and the clinical performance of your IVD device in order to prepare...
Within this e-Learning you will learn how to efficiently update your Technical Documentation, how to handle the need for adapted and/or new reports and how to incorporate the new requirements into your existing structures.
Within this e-Learning you will learn what the new requirements for post-market surveillance (PMS) and vigilance are under the IVDR and what the new requirements on trend reporting and post-market performance follow-up (PMPF) include. In the bonus...
Within this e-Learning you will get an overview on the main objectives, the underlying regulations, important stakeholders and the overall structure of EUDAMED (European Database on Medical Devices) and the UDI (Unique Device Identification) system...
Within this e-Learning we will take you by the hands to show you based on a virtual example what points need to be considered when starting the IVDR transition adventure – from the initial thoughts up...
The web-Seminar will take place on 10.11.2020 from 10:00-12:00 and 14:00-16:00 and on 11.11.2020 from 9:30-12:00 and 13:30-16:15. During the lunch break you will have time to work on exercises independently.
The web-Seminar takes place in two training units on two consecutive days from 9:00 - 14:00 including a lunch break.
New web-Seminar!
The web-Seminar will take place on 01.12.2020 (Part 1&2) and 02.12.2020 (Part 3&4) from 10:00-12:00 h and 13:00-15:00 h CET.
New Web-Seminar!
The web-Seminar will take place on 08.12.2020 and 09.12.2020 from 10:00-15:00 h CET on both days (incl. breaks).
The web-Seminar will take place on January 26, 2020 from 9:00-17:00 h CET, including breaks.
New Web-Seminar!
New Web-Seminar!
The web-Seminar will take place in two sessions (2 hours per session).
This session will provide a high-level overview of the Toxic Substances Control Act (TSCA)
Understanding the recent paradigm shift in the US new chemical review framework and the current scientific assessment process will assist companies with proper business planning and helps to ensure chemicals get to market in a timely fashion.
Understanding the statutory requirements and record keeping responsibilities under TSCA section 8(c) and establishing an internal 8(c) program is essential for a company’s overall TSCA compliance program.
Manufacturers, importers, processors and distributors of chemical substances in commerce have a reporting obligation under TSCA section 8(c) when new information is obtained that potentially indicates a conclusion of substantial risk to health or the envi
Exporters of certain industrial chemical substances or mixtures are required to notify the U.S. EPA of export activities and it is important to understand the statutory requirements and the notification process.
Importers of chemical substances or mixtures into the U.S. must make a certification regarding TSCA compliance before beginning import activities.
The type of new chemical submission and U.S. notification strategy has become increasingly important with the changes to TSCA Section 5 under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Certain types of polymers may qualify for reduced regulatory requirements under the U.S. Toxic Substances Control Act.
It is not always clear from the new chemical notification forms what type of information is important to provide the U.S. EPA to properly inform the risk assessment and reduce delays.
This session will highlight available freeware tools that can be used to conduct a preliminary risk assessment before submitting new chemical notifications to the U.S. EPA to anticipate potential regulatory concerns and identify critical outcomes.