fdas-cloud-compliance-regulations

FDA's Cloud Compliance & Regulations

Live Webinar

  • 90 minutes
  • 0 Day Left
     Jan 23, 2020
  •   01:00 PM - 02:30 PM ET
    10:00 AM - 11:30 AM PT

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.

Join this webinar with our expert Angela Bazigos where she 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.

Session Highlights:-

  • 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

Why you should Attend:-

Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records.

Who should attend:-

  • Project/Strategic Management

  • Assurance Staff

  • IT Staff

  • Operations Staff

You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it at your convenience.





Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. 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 Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been 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 Life Sciences industry.

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