The FDA and other Health Authorities worldwide have focused their attention on data integrity. The intent of Computer System Validation (CSV) is to ensure that computerized systems are developed and configured such that data integrity risk is reduced to an acceptable level. In today’s world, a company’s computerized systems may exist as cloud-based services. Such Software-as-a-Service (SaaS) models are hosted remotely and can be quite complex. Unfortunately, many of the companies that the instructor has audited have commercial off-the-shelf systems in place that show evidence of numerous data integrity issues. These issues are the result of either deliberate or inadvertent inadequate configuration and validation. Often SaaS providers are unaware of the regulatory requirements of their customers.
This Computer System Validation Training course is intended to be an introduction to the terminology and documentation requirements and the regulatory basis of CSV in the regulated Life Sciences industries. Although many companies outsource their Information Technology support or rely on cloud-based services, ultimately, compliance responsibility falls solely upon the Life Sciences company. This responsibility also extends to those US companies sourcing their supplies from foreign manufacturers or conducting clinical trials in other countries. As such, it is in the best interest of those responsible for computerized systems to understand the regulatory basis, documentation, testing and controls required to meet regulatory expectations and avoid regulatory action from Health Authorities.
Topics covered in this seminar include the concepts of Part 11 compliance, data integrity and risk management, quality management systems associated with CSV, privacy issues, testing and documentation, and the software life cycle. Techniques for conducting internal audits of computerized system will also be discussed. Several sessions will be conducted as interactive exercises.
This Computer System Validation Training course is intended for Life Science companies such as pharmaceutical manufacturers (both drug substance and drug product), medical device manufacturers, and those companies conducting or sponsoring clinical trials. In addition to these regulated companies, this course will be of value to software vendors and SaaS/cloud providers.
This CSV Training Course will benefit those responsible for the selection, implementation, validation, and maintenance of computerized systems in the Life Sciences industry. These include regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GMP / GCP / GLP applications.
Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. Eric is a 30-year industry veteran having led and coached global organizations through a wide variety of quality and compliance challenges. Complementing his leadership experience is an extensive hands-on skillset including audit management and response, Quality System remediation, software quality (including cybersecurity and AI/ML), medical device design controls, risk management, and regulatory due diligence.<,p>
Prior to King & Spalding, Eric led global technical and quality functions at Philips, Medtronic, GE Healthcare, Boston Scientific, and Hologic.
Prior to entering the medical device industry, Eric led a software quality management and program management office consulting capability in the Washington, DC area and held software design and development leadership roles in a small startup, a mid-size healthcare software company, a large financial services regulator and stock market, and a large retail organization.