Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory Pitfalls

Unfortunately, we have had to postpone this course.  We are working with the instructor to schedule a new date.  If you would like to be informed of the new date – and receive a coupon code for 20% off – please email info@lifesciencetraininginstitute.com.  We apologize for the inconvenience.

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Date: May 2, 2017
Time: 1:00pm-2:30pm, EDT US
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Course Description 

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:

  • Why you’ll be cited: deficiencies with data capture, storage and validation
  • How to develop SOPs that will mitigate risks and avoid costly setbacks
  • Prepare for, survive, and thrive under any audit or enforcement action

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:

  • Top examples of Consent Decrees focusing on CSV
  • Interpretation of past, present and future changes to FDA Guidance’s surrounding CSV
  • Financial and compliance impact to FDA’s current enforcement trends
  • Current CSV industry techniques and philosophies being deployed in the pharmaceutical marketplace for product quality and audit success
  • Utilization of automated CSV tools to ease overall validation programs

 

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.