FDA’s Cloud Compliance & Regulations

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