FDA Compliance and Mobile Applications


Duration: 90 Minutes  

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In this webinar the attendees will learn how to apply FDA guidance for computer system validation to mobile applications, and also best practices for maintaining a mobile application in a validated state.
Carolyn Troiano   Product Id : 501505
  Instructor : Carolyn Troiano

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Overview:

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.

In this webinar, the attendee will learn how to apply FDA guidance for computer system validation to mobile applications. 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.

Why should you Attend: 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.

Areas Covered in the Session:

  • 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

Who Will Benefit:
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing and Supply Chain Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
  • Business System/Application Testers in FDA-Regulated Functional Areas
  • Any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance


Speaker Profile
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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.




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