2021 PDA Annex 1: Better Compliance through Virtual Reality Webinar

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Dear Colleagues,

We are proud to present this free webinar on the possibilities of Virtual Reality (VR) kindly supported by Innerspace!

Since the EU GMP Annex 1 serves as a guide for sterile medicinal products, the new version is expected to include high requirements for personnel and their behavior, especially when they work in class A/B. This seems justified since personnel have been shown to be the main source of microbiological contamination. However, both the training and the evaluation of operator behavior are associated with numerous challenges where conventional training methods often reach their limits. These high demands on training can only be successfully met with systems that are able to confront operators with all relevant human errors on an experience-based basis and provide precise feedback on misbehavior at the individual level. Furthermore, Annex I speaks of the need to implement systems that are both suitable for the exclusion of personnel from access to cleanrooms and, after exclusion, receive tailored follow-up training that concludes with a performance review and re-qualification to work in the cleanroom.

Simulators in virtual reality seem to be highly suitable for fulfilling these requirements, since mission-critical behavior can be effectively trained and precise behavior measurement as well as standardized success control are possible. The presentation deals with opportunities and limitations in the use of such simulators and shows on the basis of best practices and lessons learned, where simulators can be helpful to meet the Annex I requirements. The webinar further introduces a methodology to systematically test requirements of regulatory guidelines related to operator training for their feasibility in simulators.

Join the discussion with our experts Sebastian Scheler, Co-Founder and Chief Methodologist at Innerspace and Alexander Stoll, Vice President - Head of Competence Center Microbiology & Aseptic Technique at Fresenius Kabi. Save your spot today!

Stay tuned for a detailed agenda out soon! We look forward to welcoming you online!

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