A Risk Based Approach to IT Infrastructure Qualification, Compliance & Control Course | Understanding Risk Assessment in FDA-Regulated Computer Systems (ONLINE EVENT: October 21, 2025) - ResearchAndMarkets.com

The "A Risk Based Approach to IT Infrastructure Qualification, Compliance & Control" has been added to ResearchAndMarkets.com's offering.

The FDA has intensified its focus on data integrity in computer system validation during inspections and audits, emphasizing the critical role of compliance in systems utilized across regulated industries. These systems are integral in the creation, collection, analysis, management, transfer, and reporting of data in accordance with FDA regulations, involving both structured and unstructured data types. This scrutiny brings to light the necessity of robust validation practices to ensure data integrity and protect product quality, process fidelity, and consumer safety.

We delve into the best practices and strategic approaches for assessing computer systems involved in FDA-regulated activities. Evaluating the potential risks associated with system failures is crucial to maintaining data integrity, upholding process and product quality, and ensuring consumer and patient safety. Critical to this exploration is the System Development Life Cycle (SDLC) approach tailored to risk assessment, alongside a discussion on the significance of adhering to 21 CFR Part 11 in managing electronic records and signatures accurately.

The discussion extends to validating and qualifying infrastructure components for FDA-regulated systems, including those utilizing cloud-based servers and Software as a Service (SaaS) solutions. A unique methodology is requisite for conducting audits and performing Installation Qualification (IQ) for systems supported by third-party vendors. Moreover, we will highlight essential policies, procedures, supporting documentation, and activities needed to ensure compliance with FDA standards.

Preparation for FDA inspections and vendor audits requires detailed best practices, which we will outline. Leveraging industry best practices centered around data integrity and risk assessment is paramount for assisting all Good Practice (GxP) activities. These insights will equip organizations to manage and mitigate risks effectively, ensuring systems remain compliant and resilient against potential integrity breaches.

In sum, the evolving landscape of regulatory scrutiny mandates an unwavering commitment to maintaining rigorous compliance practices. By implementing leading industry strategies, organizations can safeguard their operations against data integrity risks, thereby securing the trust of regulators and consumers alike. This framework not only strengthens compliance but also enhances the overall quality and safety of products and services offered across regulated sectors.

Who Should Attend:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Life sciences vendors and consultants involved in validation & compliance

Key Topics Covered:

• Identify Systems
• CSV approach based on FDA requirements
• Computer Software Assurance (CSA) concepts
• Cloud and SaaS validation and IQ practices
• SDLC framework for risk-based validation
• Validation documentation best practices
• Maintaining validated state through lifecycle
• Data integrity assurance in GxP activities
• Compliant GxP documentation strategies
• Key policies/procedures for system validation
• 21 CFR Part 11 electronic records/signature controls
• Regulatory influences on FDA expectations
• Performing computer system risk assessments
• Validation rationale using size, complexity, risk
• Audit prep for FDA inspections
• Vendor audit execution and documentation
• Best practices for maintaining compliance & data integrity

Speaker

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.

For more information about this training visit https://www.researchandmarkets.com/r/bkjpk0

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