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.

Why Should You Attend

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.

Agenda

Session 1: Introduction to FDA CSV Compliance

• Overview of Computer System Validation (CSV)
• Regulatory requirements: FDA 21 CFR Part 11, GAMP 5, and Data Integrity
• Importance of CSV in regulated industries

Session 2: Recent FDA Trends and Enforcement Actions

• Key FDA expectations for CSV compliance
• Analysis of recent FDA warning letters and 483 observations
• Common compliance pitfalls and how to avoid them

Session 3: Risk-Based Approach to CSV

• Understanding risk-based validation strategies
• Best practices for applying risk assessment methodologies
• Leveraging CSA (Computer Software Assurance) principles for compliance efficiency

Session 4: Data Integrity and Audit Readiness

• Ensuring compliance with ALCOA+ principles
• How to prepare for FDA audits and inspections
• Strategies for maintaining validation documentation and traceability

Session 5: Emerging Technologies and Compliance Challenges

• Impact of AI, cloud computing, and automation on CSV
• Validation strategies for Software as a Service (SaaS) and cloud-based systems
• Addressing cybersecurity and data privacy concerns in CSV

Session 6: Best Practices and Case Studies

• Real-world case studies on successful CSV implementation
• Industry best practices for maintaining continuous compliance
• Interactive Q&A and expert discussion on FDA trends

Who Will Benefit from This CSV Training?

This training is designed for professionals in FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and healthcare. It is ideal for:

• Quality Assurance (QA) & Compliance Professionals – Ensuring adherence to FDA regulations and industry best practices.
• Regulatory Affairs Specialists – Staying up to date with evolving FDA enforcement trends and expectations.
• IT & Software Validation Teams – Implementing effective CSV strategies for computerized systems.
• GxP System Owners & Administrators – Managing compliance for validated systems in pharmaceutical and medical device environments.
• Auditors & Inspectors – Understanding common FDA findings and preparing for inspections.
• Manufacturing & Operations Managers – Ensuring compliance in automated manufacturing and data-driven environments.
• R&D and Clinical Teams – Maintaining compliance in electronic record-keeping and software validation.