Computer Systems Validation (CSV) warning letters and overall enforcement action has increased significantly over the last five years. Particular focus on CSV has occurred, in part, due to the growing number of clinical trials and increase in data generation streams. Enforcement actions have resulted in longer regulatory approval times, increased generic competition, and growing costs for overall product development.
This course will focus on the current top five FDA regulatory trends, warning letters and enforcement actions related to Computer Systems Validation (CSV), where you will learn the following:
Additionally, the learning objectives of this course will focus on preventing CSV outcomes that will have a negative impact on patient safety and your profitability. During this interactive 90-minute session, you will learn:
This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control 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.