Speaker: Carolyn Troiano
Speaker Designation: FDA Compliance Consultant
The webinar will take a closer look at testing as a crucial aspect of Computer System Validation (CSV) in compliance with FDA requirements. It is imperative to determine the appropriate type and level of testing during validation based on the potential risks associated with a system malfunction, as well as its categorization according to GAMP®5, Second Edition, and a thorough risk assessment. An overview of the approach for determining the type and level of testing will be provided, based on these and other factors.
The webinar will emphasize the importance of adhering to industry best practices for testing IT systems used in FDA-regulated environments, wherein the system is used for data, documents, and other artifacts related to a product during manufacturing, testing, or distribution. Such systems must be validated in compliance with FDA guidelines for computer systems and adequately documented. Testing plays a crucial role in the System Development Life Cycle (SDLC) as part of the validation phase.
The course will cover best practices for testing, outlining who should be responsible for specific tasks, how testing should be conducted, and the specific criteria used to define acceptance, per FDA guidelines. Attendees will learn to develop a detailed rationale for testing, ensuring full execution and documentation in line with FDA requirements. We will cover different methodologies that align with the SDLC, including waterfall and agile. We will also discuss the use of automated testing.
The webinar will address 21 CFR Part 11 and data integrity, providing insight into how you can navigate the requirements and testing to meet each of these guidances from the FDA.
The webinar will provide guidance for maintaining the system in a validated state and evaluating any necessary testing post-validation to ensure compliance.
You will learn about the importance of software vendor contracts and service level agreements (SLAs) as a means of ensuring the vendor will maintain the system appropriately.
In this Webinar course speaker, Carolyn Troiano will discuss ways to minimize costs while assuring maximum compliance with FDA requirements for CSV.
Upon completion of this session, attendees will have an understanding of computer system testing concepts and how these efforts are to be adequately documented to meet FDA requirements. They will understand the steps required for documenting the test planning, execution results, and summary reporting. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for testing.
Personnel in the following roles will benefit:
Carolyn Troiano has more than 40 years of experience in computer systems and data in the pharmaceutical, medical device, tobacco, cannabis, and other FDA-regulated industries, as well as in banking, insurance, and government agencies. She is currently an independent consultant, advising companies on data integrity, privacy, and compliance, including implementing large-scale, complex systems, such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Clinical Trial Master File (TMF and eTMF), Manufacturing, Quality, and Enterprise Content Management (ECM) systems.
