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).
Why should you attend/Description of the topic:
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.
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
Who will benefit:
Pharmaceutical, consumer products, and medical device companies, operating within the scope of FDA regulatory authority.
SQA, DIA, ISPE, PDA, RAPS
For FDA regulated companies, any staff members who may be involved with the project planning, validation testing, regulated use, system support, and compliance of computerized systems out-sourced to cloud environment hosting facilities.
Duration: 90 Minutes
Group of 3 to 5
Group of 6 to 10 + DVD-USB
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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 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. 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 Lifesciences industry. More recently, Ms. Bazigos was quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ and is working with the FDA to define those metrics that will be used for compliance at the Boardroom level. She is also assisting the FDA with updating their guidance "General Principles of Software Validation" (published in 2002)