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Validity : 19th Apr'24 to 29th Apr'24
Policies and Procedures for Computer System Validation (CSV) and FDA Compliance
• Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Understand “GxP” Systems
• Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
• Learn about the key policies and procedures necessary to support the validation effort
• Learn about the key policies and procedures necessary to support the maintenance of your system in a validated state
• Learn how to ensure, through complete and well-organized policies and procedures, that all your validation work will be defensible during an FDA inspection
• Q&A
Overview of the webinar
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
In order to perform a complete and thorough validation effort, many companies rely on a series of policies and procedures for guidance. Those that have prescribed deliverables will also have templates associated with them to ensure your work is done consistently across your organization.
In this webinar, we will look at the computer system validation process, which is based on the System Development Life Cycle (SDLC) methodology, and the specific actions and deliverables required to complete this work, and to maintain the system in a validated state. The SDLC includes a series of deliverables, each of which will be described, along with the policies and procedures necessary to guide you through completing them.
We will also look at the policies and procedures necessary to maintain the integrity of the data on your system by maintaining the system itself in a validated state.
There are also policies and procedures that address the “people” portion of validation, including training and organizational change management, and we will describe these as well.
Finally, we will cover good documentation practices, as these must be followed for all computer system validation deliverables to ensure they will be defensible to FDA.
Who should attend?
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Clinical Data Managers and Scientists
• Quality Managers, Chemists and Microbiologists
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
Why should you attend?
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.
This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.