Validating and Auditing Cloud, SaaS, IaaS, PaaS Systems - Tech & Validation Trends for FDA Compliance

About The Course:

For over three decades, the FDA has overseen computer system validation (CSV) in the pharmaceutical, biotechnology, medical device, and other regulated industries. This ensures comprehensive planning, implementation, testing, and management of computer systems that handle data. The introduction of Electronic Records and Electronic Signatures (ER/ES) in 1997 through FDA's 21 CFR Part 11 established the standards for validating these systems.

By the early 2000s, the FDA shifted the responsibility to industry, requiring companies to assess systems based on risk. Key factors include system size, complexity, business criticality, GAMP 5 category, and risk rating, which determine the scope and rigor of testing needed for data integrity and product safety.

The FDA's recent focus on data integrity has highlighted its importance in compliance. Systems that interact with FDA-regulated data must maintain integrity throughout their lifecycle. This includes databases and various unstructured data formats.

This seminar explores best practices for evaluating computer systems in FDA-regulated activities, focusing on potential risks to data integrity, product quality, and patient safety. We cover the System Development Life Cycle (SDLC) approach to validation and the importance of 21 CFR Part 11 compliance.

We also address validating and qualifying cloud-based infrastructure components, including SaaS, PaaS, and IaaS solutions. Special attention is given to auditing and performing Installation Qualification (IQ) for these systems.

Guidance on conducting vendor audits for non-premise solutions, qualifying cloud-based vendors, and leveraging vendor documentation to reduce validation costs and time will be provided. We discuss key areas for client-vendor discussions and best practices for negotiating vendor contracts and Service Level Agreements (SLAs).

Additionally, the seminar outlines essential policies and procedures for compliance and offers strategies for preparing for FDA inspections. We conclude with industry best practices focused on data integrity and risk assessment to enhance GxP activities.

Why You Should Attend:

This seminar is crucial for professionals in FDA-regulated industries involved in developing, manufacturing, testing, and distributing products. Ensuring proper validation and auditing of cloud-based systems is essential for data integrity and compliance. With the FDA's increasing focus on data integrity, robust validation practices are critical for protecting product quality and patient safety.

You will gain practical guidance on evaluating and validating computer systems, managing change control processes, and performing effective vendor audits. Learn to navigate the complexities of cloud-based system validation, leverage vendor documentation, and implement best practices for negotiating SLAs. Additionally, prepare for FDA inspections and maintain compliance throughout the system lifecycle.

Ideal for those responsible for planning, executing, or managing FDA-regulated systems, this seminar equips you with the knowledge and skills to ensure your systems are validated, compliant, and secure.

Areas Covered:

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work
• Learn about cloud service and SaaS providers and the best approach for conducting a vendor audit and performing Installation Qualification (IQ) for validation
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
• Understand how to maintain a system in a validated state through the system’s entire life cycle
• Learn how to assure the integrity of data that supports GxP work
• Discuss the importance of “GxP” documentation that complies with FDA requirements
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
• Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
• Learn about newer industry and FDA compliance trends
• Learn about newer technologies, including Artificial Intelligence (AI), Machine Learning (ML), Blockchain, and Distributed Ledger Technology (DLT))
• Learn how to best prepare for an FDA inspection or audit of a GxP computer system
• Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle

Who Should Attend:

This seminar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance. Examples of who will benefit from this webinar include:

• 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

This seminar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

AGENDA

Course Director: CAROLYN TROIANO

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.