Cloud Computing in a Regulated Environment with Thescon Expert Alexander Blüml
Cloud Computing
The trend of partially or fully outsourcing GMP data management has steadily increased. Cloud computing is the provision of IT resources such as servers, storage, databases, network components, software, analytics, and intelligent features via the internet. In the era of Big Data, cloud computing offers not only economic advantages (lower capital investment and reduced ongoing IT costs), but also benefits like high availability of systems and data, IT decentralization, and reduced effort for backups and data mirroring.
Cloud Computing in Regulated Environments
As a company operating in a regulated industry, you face the challenge of complying with applicable regulatory requirements (e.g., Eudralex, AMWHV, DIN EN ISO 13485:2016, EU GDPR, 21 CFR Part 820, Medical Device Regulation) while managing the risks associated with cloud computing (e.g., data protection and security).
Cloud Computing in Practice
This webinar explores the advantages and disadvantages of cloud computing in depth. You’ll gain insights to help determine when and which cloud solutions are viable alternatives.
What to Expect
- What is Cloud Computing?
- Origins of Cloud Computing
- Cloud Computing vs. Outsourcing
- Definitions
- Service Models
- Deployment Models
- Regulatory Foundations
- Eudralex
- AMWHV
- DIN EN ISO 13485:2016
- EU GDPR
- 21 CFR
- Validating and Qualifying Cloud Services in Practice
- Validation vs. Qualification
- Framework
- Lifecycle Model
- Qualification of Service Models
- Practical Questions from Everyday Work
- What types of Cloud Computing exist: IaaS, PaaS, SaaS, XaaS?
- Which regulatory requirements must be observed?
- What risks do cloud solutions pose and how can they be managed?
- How can system compliance be ensured?
- How are cloud services validated and qualified?
The webinar will take place on May 9, 2025, from 10:00 to approximately 11:30 AM.
Register here: