Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory Pitfalls
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.
Robert J. Finamore serves as the Director of IT Compliance and Validation for QPharma, Inc., a regulatory compliance consulting firm based in Morristown, NJ. He has been a leader at QPharma over the past 15 years in the management and execution of hundreds of regulatory compliance projects, and is a recognized expert in computer system validation and 21 CFR Part 11 compliance. Rob currently oversees the IT Compliance practice within QPharma, which executes regulatory compliance projects in the fields of validation, quality systems, training, and auditing for life sciences customers and vendors.