Webinar series:
Practical know-how; digital tools and processes needed to implement a medical cloud
Sign up to receive an invitation to this free webinar series that will be hosted by Ductus in September and October 2020. One webinar will focus on data integrity (FDA Title 21 CFR Part 11) while the other will bring you insights into how to successfully implement a medical cloud, both from a regulatory and technical point of view. You will also get the opportunity to ask questions to our experts, either during the Q&A session or you could book a separate meeting. The invitations will be sent out early September.
Topics that will be covered during these webinars include:
- GAP-analysis; Data collection plan; Validation plan; Internal process change plan
- How much will It cost? Off-the-shelf with modification vs custom development
- Operational/deployment of Validated GxP medical cloud
- Regulatory aspects: Technical filing (PMA/510k), FDA Title 21 CFR Part 11 Data – integrity, Post-Market Surveillance Plan (PMSP)
- Intellectual property and flexibility in modification and implementation of new functionality
- Cloud Service provider independence and data migration
- Go to market plan; value for end-customers, value for distributors