FDA’s Cloud Compliance and Regulations

Recorded Webinar | Angela Bazigos | From: Apr 03, 2020 - To: Dec 31, 2020

Training Options & Pricing

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Recording     $229
DVD     $249
Recording + DVD     $389
Transcript (Pdf)     $229
Recording & Transcript (Pdf)     $379
DVD & Transcript (Pdf)     $389

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Description

The evolution of computerized technologies has been both amazing and challenging.  Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements.  Cloud computing is a current example of this evolution.  This presentation will provide a discussion of Cloud concepts, terminology, definitions, architecture, and services; review the contradictions and challenges of using a cloud environment to support regulated activities; discuss assessments of cloud hosting facilities; and stress the importance of a detailed Service Level Agreement (SLA). 

Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud-based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.  This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud-based system.

Areas Covered in the Session:-

  • Understanding the Cloud Definition
  • The Basics – Architecture & Services
  • Contradictions and Challenges
  • Cloud Provider Assessments
  • Compliance – Past, Present, Future
  • The Service Agreement
  • Closed vs. Open Systems 
  • Perspective / Compliance Notes / Conclusions
  • Questions & Discussion

Who will benefit:-

  • Project/Strategic Management
  • Assurance staff
  • IT staff
  • Operations staff
 
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