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.
15 years of Life Sciences Compliance and Quality Assurance experience with specific emphasis on Computerized Systems Compliance and Validation, and Electronic Data Integrity.
Proficiency with FDA 21 CFR Parts 11, 210/211, 820, etc., EU EMA Annex 11, ISPE GAMP 5, FDA GxP, FDA and EMA guidance, IEEE and ISO Standards, SDLC and VLC models, Infrastructure Qualification, FMEA, etc.
Initial deployments and continuous improvement of all aspects of IT-centric Quality Management Systems in regulated environments, including Compliance, SDLC/Project, Operations, and Retirement.
Experience with high criticality efforts such as system validation and quality measures deployed to meet FDA Consent Decree obligations, systems in use by 100,000+ worldwide users, etc.
Organizational leadership through trust-based relationships, personnel development and collaboration.
Instinctively analytical and fundamental decision making that establishes alignment of process, technical, regulatory, and quality requirements in support of enterprise and business unit objectives.