Dr Ulrich Kissel
Dr Kissel is Chairman of the Board of Directors of the European QP Association (EQPA) and Director Regulatory Affairs on the Executive Board of the European Compliance Academy (ECA).
Due to the current Sars-CoV-2 outbreak, more and more people have started working from home; this includes Qualified Persons (QPs) but also auditors. But what do the regulators say when it comes to batch certification and remote audits?
The interpretation of the requirements by national inspectorates and their respective expectations are not harmonized across the European Union/EEA/UK. Some agencies like MHRA and HPRA are starting their own initiatives. The whole situation puts a lot of additional responsibility and pressure on the QPs. Transparency and information sharing is now very important.
This Webinar has been designed for EU Qualified Persons (QP) but also QA personnel, upper management functions and other interested people who want to be informed about the current situation for QPs.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
This webinar will give you a comprehensive overview of the ongoing initiatives and discussions on possible QP flexibilities and responsibilities during the Sars-CoV-2 outbreak like:
- Remote certification (regulators’ point of view)
- Remote certification (industry’s point of view)
- Impacts in production or quality control
- Extended QP Discretion
- Use of remote audits