Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to 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 attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Why Should You Attend:
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:- Discuss 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
- Stress the importance of a detailed Service Level Agreement (SLA)
Areas Covered in the Webinar:
- Understanding the Cloud Definition
- The Basics - Architecture and Services
- Contradictions and Challenges
- Cloud Provider Assessments
- Compliance - Past, Present, Future
- The Service Agreement
- Closed vs. Open Systems
- Perspective/Compliance Notes/Conclusions
- Questions and Discussion
Who Will Benefit:
- Project/strategic management
- Quality assurance staff
- IT staff
- Operations staff
- Any staff members in FDA regulated companies involved with project planning, validation testing, regulated use, system support, and compliance of computerized systems out-sourced to cloud environment hosting facilities
Course Provider
Angela Bazigos,
