Live Webinar Current Concepts & Challenges in Cloud Compliance

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Description

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

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

•    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

•    Project/Strategic Management
•    Quality Assurance staff
•    IT staff
•    Operations staff

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, consumer products, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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