Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 21st Apr'24 to 01st May'24
Mobile Applications and Computer Systems Regulated by FDA
• Gain an understanding of how mobile applications should be handled when performing validation work
• Understand the best practices for maintaining a mobile application in a validated state
• Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
• Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
• Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
• Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications
• Q&A
Overview of the webinar
We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will detail the key areas of focus, including security, access and change control, along with the documentation that is required to create a complete and compliant validation package in a cost-effective manner.
This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit.
Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.
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?
You should attend this webinar if you are responsible for planning, executing or managing the validation of a system governed by FDA regulations that incorporates mobile software or devices into the system structure.
Upon completion of this session, attendees will have an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements. They will understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized.
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.