FDA Compliance And Mobile Applications
  • CODE : CARO-0051
  • Duration : 90 Minutes
  • Level : Intermediate
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Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid, and other FDA-regulated industries. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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.

Areas Covered

  • 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 the validation of mobile applications, as the 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

Course Level - Intermediate

Who Should Attend

  • 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
  • Risk Management Professionals
  • 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
  • Vendors responsible for software development, testing, and maintenance
  • Vendors and consultants working in the tobacco and related industries who are involved in computer system implementation, validation, and compliance

Why Should You Attend

You should attend this seminar if you are responsible for planning, executing, or managing the validation of a system governed by FDA regulations that incorporate 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 approach to the validation process.

Topic Background

This topic is focused on the use of mobile applications to process data regulated by the FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to the 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, and 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.

  • $179.00



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