Cloud computing continues to be a disruptive force in technology, with global SaaS software revenues forecasted to reach $106B in 2016, increasing 21% over projected 2015 spending levels.
Advantages of moving to the cloud are many and include cutting costs and improving agility. However, there are many disadvantages as well. These risks are of particular importance to the regulated industry and must be understood and mitigated for compliance.
The focus of this training is to understand how to transform traditional vendor and infrastructure qualification activities and software validation activities into actionable steps for ensuring compliance in the cloud, whether it be with IaaS, Paas, or Saas approach. The outcome will be changing your highest risks in to three key success factors. Each factor will be reviewed in depth for real-world application.
Learning objectives include:
This course will be of benefit to anyone involved the selection, acquisition, validation, use, or maintenance of cloud computing services (Infrastructure-as-a-Service, Platform-as-a-Service, or Software-as-a-Service) used within GxP environments. This course will be highly-relevant to those in Quality Assurance, Compliance, Validation, IT, Procurement, and other job functions which are impacted by CSV efforts. This course is particularly useful to those who interface with vendors, FDA, and other regulatory agencies.
Alecia Adams, RQAP-GLP, PMP, ASQ CSQE, is a software implementation and compliance consultant and the founder of Compliant Systems Services, LLC, in Naples, FL. She helps biotechnology, pharmaceutical, and medical device companies find and implement computerized systems that increase efficiency, sustain compliance, and ease business pain. Ms. Adams has 17 years of combined experience in technical operations, quality assurance, and information technology. She earned her B.S. in Biochemistry from the University of Southern Mississippi and is continuing her education at the Johns Hopkins University, where she is earning her M.S. in Bioinformatics and focusing on the potential of big data and cloud computing in the area of personalized medicine. She is an active member of the American Society for Quality (ASQ) as well as the Society of Quality Assurance (SQA) and its Computer Systems Validation Initiative Committee (CVIC). Ms. Adams also volunteers her time as a Scientific Project Manager for the Rare Genomics Institute.