FDA’s Cloud Compliance and Regulations
Angela Bazigos is the CEO of Touchstone Technologies Inc.
Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer, IT Director & QA Director. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Food / Public Health Service, and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA and work with FDA on Data Integrity Regulations. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in the 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/ National Trainer for Society of Quality Assurance. Comments / collaborates with the FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.
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).
- 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
Course Level - All
Who Should Attend
- Project/Strategic Management
- Assurance staff
- IT staff
- Operations staff
Why Should Attend
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.