FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.

In particular, we will focus on best practices for validating computer systems regulated by FDA and meeting compliance with electronic records and electronic signatures (21 CFR Part 11). We will also provide current FDA trends, including a focus on data integrity issues in industry, which will be illustrated through industry examples.

The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.

Effective and compliant computer system validation is critical to any FDA-regulated organization. FDA has set forth very specific requirements for meeting compliance, and a very prescriptive set of enforcement actions to protect patient and/or consumer safety. This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits, and gain insight to the level of enforcement associated with various findings, consent decrees and warning letters. Examples from industry will be used as case studies to illustrate these.

It is vital for regulated companies to maintain a pulse on the regulatory environment in order to fortify system validation efforts, as necessary, to meet FDA expectations. It is the best practice to have a robust computer system validation, continue executing against it consistently, and documenting it thoroughly. By maintaining a strong and consistent computer system validation program, companies can further build trust with FDA and the consumers who rely on such oversight for protection.

• FDA Regulatory Oversight
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• GAMP 5 Software Categorization
• System Risk Assessment
• Requirements, Design, Testing
• Requirements Traceability Matrix (RTM)
• Validation Documentation
• 21 CFR Part 11 Compliance (Electronic Records/Signatures)
• Audit Preparation
• Most Common Problems with CSV
• Best Practices

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

Consulting/Training in FDA Compliance for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity

Carolyn Troiano has more than 40 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Event Venue

Online