Current Concepts and Challenges in Cloud Compliance

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

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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