Current Concepts and Challenges in Cloud Compliance

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.

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Last Recorded Date: Feb-2019

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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
Instructor Profile:
Angela Bazigos Angela Bazigos

CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include:

  • Chief Compliance Officer, http://morflearning.com/angelabazigos/.
  • QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA.
  • Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx.
  • Patent on speeding up software compliance https://www.google.com/patents/US8266578.
  • Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/.
  • Comments / collaborates with FDA on new guidance documents.
  • Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.
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