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WEBINAR: Leveraging the GxP Cloud - Crucial Steps to moving GxP regulated systems to the Cloud

Wednesday, September 20, 2017, 01:00pm - 02:00pm

Wednesday, September 20 at 1pm EST, 10am PST


Leveraging the cloud is fast becoming a mainstream discussion within Pharmaceutical and Life Sciences companies – most employing a ‘cloud first strategy’ to deploying new applications and systems. Despite the clear benefits the cloud brings to IT departments – like competitive pricing, scalability, flexibility and disaster recovery options – this industry must still focus on compliance first, including its validation/qualification strategy for both software and infrastructure, management of computerized systems, change control and audit readiness.

Taking this all into account, what should IT executives and professionals consider in their own approach to the cloud and especially its effect on data integrity?

In this webinar we will explore crucial steps that are required by the FDA when implementing in the cloud. We will also explore a case study of one company’s road to success, the vendor assessment process, their approach to leveraging cloud technology for their SaaS based platform, and the importance of ensuring they meet Part 11 requirements for both the software and infrastructure it’s installed on.

45 minute GxP cloud webinar topics:

What basic information do you need from a cloud provider for compliance?

  • Agency expects that regulated companies will address: Supplier quality, risk management, system validation
  • Linking supplier activities/documents to internal quality system documentation

How does the cloud infrastructure affect data integrity?

  • Managed Services
  • Security solutions

What key points should be covered in a quality agreements with cloud vendors?

  • To mitigate risk in quality, regulatory and operational areas

Considerations for the cloud vendor assessment including

  • Risk based approach to the data center selection process
  • Vendor audits

GxP cloud for SaaS based companies – risks, benefits and trends

  • Outline of the GxP cloud responsibility matrix
  • Cloud provider and regulated entity




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