Overview:
In this webinar, we will delve into the critical aspects of applying computer system validation to mobile applications subject to FDA regulations. Developing the right validation strategy is crucial to ensure that systems function as intended and are maintained in a validated state throughout their entire life cycle.
We
will explore key areas of focus, including security, access, and change
control, and discuss the necessary documentation to create a comprehensive and
compliant validation package in a cost-effective manner.
The
session will concentrate on mobile applications used to process FDA-regulated
data, such as data collection, analysis, transfer, and reporting. Mobile
applications are relevant across various FDA-regulated company functions,
including Quality Laboratories, Manufacturing, Supply Chain/Distribution,
Adverse Event Reporting, and Post-Marketing Surveillance, among others.
As
technology evolves, it's essential to adapt our approach to computer system
validation for FDA-regulated systems, taking into account all necessary
controls, whether technical or procedural. Mobile devices introduce additional
complexity due to their small size, portability, and vulnerability to both
physical and logical mishaps or calculated attacks.
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
Why should you attend?
- Attending this webinar will empower you with the knowledge and best practices to effectively navigate the complex landscape of computer system validation for mobile applications subject to FDA regulations.
- You will gain critical insights into maintaining a validated state for mobile applications and developing a robust validation strategy that balances cost and risk.
- This webinar will also equip you with the know-how to document the validation process comprehensively and stay up-to-date with industry trends and emerging best practices.
- By understanding the potential pitfalls in applying computer system validation to mobile applications, you will be better prepared to ensure compliance, enhance security, and optimize the use of mobile applications across various FDA-regulated functional areas within your organization.
Don't miss this
opportunity to enhance your expertise and stay ahead in the rapidly evolving
world of mobile applications and FDA-regulated systems.
What industries will benefit from this training?
Manufacturing,
Testing, Packaging and Distribution companies in the following industries that
are regulated by FDA are required to follow GxPs:
- Pharmaceutical (for drug products introduced using a medical device)
- Medical
Device
- Biologicals
(for biological products introduced using a medical device)
- Tobacco
(based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor
(based on the “Deeming” Act of 2016)
- E-Cigarette
(based on the “Deeming” Act of 2016)
- Cigar
(based on the “Deeming” Act of 2016)
- Third-Party
companies that support those in the above industries, including Contract
Research Organizations (CROs)
- Colleges
and Universities offering programs of study in Clinical Trial Management and
Regulatory Affairs/Matters related to FDA
Who will benefit?
Information Technology Analysts- Information
Technology Developers and Testers
- Software
Quality Assurance Professionals
- 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 life sciences industry who are involved in
computer system implementation, validation and compliance
This
webinar is specifically tailored to professionals in FDA-regulated industries
who are seeking to enhance their knowledge and understanding of computer system
validation for mobile applications.
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
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
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
Enrollment Options
Tags: Mobile, App, Validation, FDA, Regulation, Carolyn, Troiano, May 2023, Webinar