10 Minutes excerpt from the recorded event for your review:
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LinkedIn Article - Mastering Mobile App and Medical Device Software Validation
In this LinkedIn article we've encapsulated the entire session's discussions and insights.
Overview:
For over four decades, computer system
validation has been a critical component under FDA regulation, pivotal in the
manufacturing, testing, and distribution processes within pharmaceutical,
biotechnology, and medical device industries. The FDA's stringent requirements
ensure meticulous planning, implementation, integration, testing, and
management of computer systems that handle data crucial to product integrity
and safety.
In 1997, the FDA
further delineated the framework for Electronic Records and Electronic
Signatures (ER/ES) through the guidelines set forth in 21 CFR Part 11. This
regulation underscores the fundamental prerequisites for validating and
documenting ER/ES functionalities in FDA-regulated environments.
Recognizing the
impracticality of inspecting every computer system, the FDA, in the early
2000s, shifted the responsibility to the industry to assess regulated computer
systems based on risk. The potential risk of system failure informs the
validation strategy and scope, taking into account factors like system size,
complexity, business criticality, GAMP®5 category, and risk rating. These
components dictate the extent of testing necessary to ensure data integrity and
product safety.
Amidst heightened
scrutiny on data integrity during validations, the FDA continues to emphasize
the management and maintenance of both structured and unstructured data
throughout their lifecycle. The rise of interconnected medical devices,
including mobile medical devices and Software-as-a-Medical Device (SaMD)
solutions, introduces additional layers of complexity and cybersecurity
concerns. This has propelled the FDA to the forefront of addressing these
challenges, emphasizing the need for robust validation and compliance
strategies.
This webinar will
delve into best practices and strategic approaches for evaluating computer
systems in FDA-regulated activities, focusing on risk assessments and the
System Development Life Cycle (SDLC) methodology tailored to GAMP®5 software
categorizations. Special emphasis will be placed on the validation of mobile
applications and related infrastructure components, including cloud and SaaS
solutions. We will cover crucial policies, procedures, and documentation
required to maintain compliance and prepare for FDA inspections, ensuring data
integrity and cybersecurity are upheld across all platforms.
Areas covered during the session:
This webinar
includes the following key objectives:
- Learn how to
identify “GxP” Systems
- Learn how to
identify specific types of mobile devices, including mobile medical devices and
Software-as-a-Medical Device (SaMD) solutions and the FDA regulations that
apply to them
- Discuss the
Computer System Validation (CSV) approach based on a System Development Life
Cycle (SDLC) approach
- Learn about
Computer Software Assurance (CSA) and how this approach may streamline your
validation work
- Learn about cloud
service and SaaS providers and the best approach for conducting a vendor audit
and performing Installation Qualification (IQ) for validation
- Understand the
cybertechnology landscape, including cyber threats and measures for preventing,
detecting, and mitigating these
- Learn strategies
for meeting 21 CFR Part 11 requirements for electronic records and electronic
signatures (ER/ES)
- Learn how to
maintain data with integrity, in accordance with the “ALCOA+” principles
- Discuss the best
practices for documenting computer system validation efforts, including
requirements, design, development, testing and operational maintenance
procedures
- Understand how to
maintain a system in a validated state through the system’s entire life cycle
- Learn about the
policies and procedures needed to support your validation process and ongoing
maintenance of your systems in a validated state
- Understand the
importance of performing a thorough vendor audit to ensure oversight to the
products and services they deliver
- Finally, understand
the industry best practices that will enable you to optimize your approach to
validation and compliance for mobile devices and software to ensure data
integrity is maintained throughout the entire data life cycle
- Q&A
Why you should
attend?
This webinar is
designed to equip attendees with the knowledge to implement the most effective
validation strategies for systems utilizing cutting-edge technologies within
FDA-regulated environments. Focus will be on mobile applications, mobile
medical applications, and Software-as-a-Medical Device (SaMD) products.
Understanding the
foundation of any computer system implementation—including the necessary
infrastructure of hardware and software—is crucial. This session will explore
how to qualify these components to support systems in a validated state. From
Commercial-Off-the-Shelf (COTS) packages to cloud services and
Software-as-a-Service (SaaS) solutions, you will gain insights into ensuring
that all supporting technologies meet rigorous FDA standards.
Additionally, we
will cover best practices for validating all types of mobile devices and
applications, ensuring they remain in a validated state throughout their
lifecycle. By attending, you will not only learn to navigate the complex
landscape of FDA regulations but also ensure ongoing compliance and integrity
in your systems and applications.
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,
E-Cigarette, Cigar (based on the “Deeming” Act of 2016)
- Providers of GxP
mobile and medical device hardware and software
- Third-Party
companies that support those in the above industries by consulting and other
professional offerings
Who will benefit?
Personnel in the
following roles will benefit:
- Information
Technology Developers & Testers
- Information
Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data
Managers
- Clinical Data
Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing
Managers
- Manufacturing
Supervisors
- Supply Chain
Specialists
- Computer System
Validation Specialists
- GxP Training
Specialists
- Business
Stakeholders responsible for computer system validation planning, execution,
reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
- Auditors engaged in the internal inspection of methods and practices
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: FDA Compliance, Mobile App Validation, Medical Device Software, Cybersecurity Medical Devices, Data Integrity, 21 CFR Part 11, Risk Assessment, GAMP 5, SDLC, Cloud Services Validation, Carolyn, Troiano, June 2023, Webinar