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Medical Devices Compliance

How to Deal with the Contradictions and Challenges of Using Cloud in a Regulated Environment

Summary

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). 

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

Who should attend?

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

Angela Bazigos

Expert

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

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