ComplianceOnline

Current Concepts and Challenges in Cloud Compliance

Instructor: Angela Bazigos
Product ID: 703739
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Fax: +1-650-963-2556

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Read Frequently Asked Questions

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.

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

Instructor Profile:

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.

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