Compliance Trainings, Online Training Session
2013-06-19
Description : 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).
This presentation will provide a baseline of information related to cloud computing which will help the attendees better in understanding the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system. read more… 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
- Questions & Discussion
Who Will Benefit: For all FDA regulated companies - Project/Strategic Management
- All Quality Assurance staff
- All IT staff
- All Operations staff
- Validation Testing
- System Support
Any staff members who may be involved with the compliance of computerized systems out-sourced to cloud environment hosting facilities.
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Invited Speakers:
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 Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.
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