Validating and Auditing Cloud, SaaS, IaaS, PaaS Systems - Tech & Validation Trends for FDA Compliance
December 16 - 17, 2024 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM
- Faculty: CAROLYN TROIANO
- Product ID: SEM2645
Learn More
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 | 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:
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
DAY 1 (10 AM to 3 PM)
| DAY 2 (10 AM to 3 PM)
|
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. |