Overview
The
landscape of computer system validation is undergoing a transformative shift
with the introduction of GAMP®5, 2nd Edition, and the FDA’s draft guidance on
Computer Software Assurance (CSA). This webinar aims to unpack these
significant developments, elucidating their impact on the validation practices
within the life sciences industry.
With
technology advancing rapidly, the life sciences sector is moving towards more
agile, efficient, and quality-focused methodologies. The webinar will explore
how GAMP®5, 2nd Edition, aligns with the principles of CSA, advocating a
risk-based and patient-centric approach over traditional, documentation-heavy
methods. This alignment signifies a move towards leveraging technology to
enhance quality and operational efficiency, without sacrificing compliance.
Attendees
will gain insights into the agile and waterfall methodologies, understanding
their pros and cons, and how they fit into the GAMP®5 “V” Model for successful
system validation. The session will also cover the nuances of validating
cloud-based solutions, including COTS, SaaS, IaaS, PaaS, and their regulatory
considerations under 21 CFR Part 11 and data integrity guidelines.
Furthermore,
the webinar will address the FDA’s current concerns and expectations,
particularly focusing on the shift towards newer technologies that facilitate
innovation without becoming a bottleneck due to regulatory constraints. The
discussion will include how CSA’s risk-based approach, coupled with GAMP®5’s
support for agile methodologies, offers a pathway to more efficient and
effective validation processes.
By
attending this session, participants will not only understand the regulatory
shifts but also how to practically apply these changes in their validation
strategies, ensuring that their systems are both compliant and aligned with
industry best practices and FDA expectations.
Areas
covered during the session:
- Learn
how to identify “GxP” Systems
- Learn
about FDA’s current thinking about technology and software development, and how
this will impact industry
- Discuss
the current state of Computer System Validation (CSV) approach based on FDA
requirements and the Computer Software Assurance (CSA) approach, based on the
draft guidance from FDA in September 2022
- Learn
about GAMP®5, Second Edition and how it aligns more closely with the CSA
approach to validation
- Learn
about the System Development Life Cycle (SDLC) approach to validation and how
this can be modernized through a more agile approach, including automated
testing for continuous validation
- Learn
about cloud services and cloud service providers to optimize your experience
- Learn
ways to validate in the cloud without compromising quality or compliance
- Learn
the pros and cons of an agile vs. waterfall approach
- We
will discuss cloud computing, Computer Off-the-Shelf (COTS) software
validation, and Software-as-a-Service (SaaS), Infrastructure-as-a-Service
(IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and
validated effectively
- Discuss
the best practices for documenting computer system validation efforts, whether
using a waterfall or agile approach, including requirements, design,
development, testing and operational maintenance procedures, including ways to
improve efficiency and effectiveness of managing related documentation
- Understand
the best approach to Installation Qualification (IQ) testing when the system
components are not on premise, but in the cloud
- Understand
how to maintain a system in a validated state through the system’s entire life
cycle in a more cost-effective manner, applying an Agile continuous validation
approach
- Learn
how to assure the integrity of data that supports GxP work, despite changes and
advances in new technology
- Discuss
the importance of “GxP” documentation that complies with FDA requirements
- Learn
about the policies and procedures needed to support your validation process and
ongoing maintenance of your systems in a validated state
- Know
the regulatory influences that lead to FDA’s current thinking at any given time
- Finally,
understand the industry best practices that will enable you to optimize your
approach to validation and compliance, based on risk assessment, to ensure data
integrity is maintained throughout the entire data life cycle
- Q&A
Why
You Should Attend?
This webinar is a must-attend for professionals in the life sciences industry who are navigating the evolving validation requirements set by the FDA. You will gain a thorough understanding of how GAMP®5, 2nd Edition, and the FDA’s CSA draft guidance intersect and the strategic considerations this alignment necessitates for your validation processes.
Participants
will learn about the transition from traditional CSV approaches to the more
flexible and efficient CSA model, which prioritizes risk management and
quality. The session will cover the practical aspects of implementing agile
methodologies and automated testing within the validation framework,
highlighting how these approaches can be integrated into your existing systems
to enhance compliance and operational efficiency.
By
joining this webinar, you will not only stay ahead of the regulatory curve but
also equip your organization with the knowledge to implement a modern,
compliant, and efficient validation strategy that leverages the full potential
of current and emerging technologies. Gain the insights needed to transform
your validation approach, aligning with the FDA’s current expectations and
preparing for the future of software assurance in the life sciences industry.
What
industries will benefit from your 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
- 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
- GMP
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 labeling records 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: GAMP5, FDA CSA, System Validation, Compliance, Life Sciences, Agile Methodology, Risk Management, Software Assurance, Quality Systems, Regulatory Guidance, Carolyn, Troiano, April 2024, Webinar