Overview:
For
over three decades, the FDA has regulated computer system validation in
industries like pharmaceuticals, biotechnology, and medical devices. These
validations ensure that computer systems involved in production, testing, and
distribution operate securely and reliably. Recently, the FDA has taken a major
step forward with its Technology Modernization Action Plan (TMAP), aimed at
modernizing the way the agency works with the industry. This development marks
a shift in focus from merely validating existing systems to also incorporating
new technologies such as cloud computing and Software as a Service (SaaS).
With
an increasing focus on data integrity, the FDA's modernization plan seeks to
set higher compliance standards for all regulated computer systems. This focus
isn't just limited to structured data; it extends to unstructured data formats
like documents, spreadsheets, and even audio-visual files. Given these evolving
guidelines, it is vital for companies in regulated industries to keep pace with
the FDA's expectations on computer system validation and data integrity.
In
light of these developments, this webinar will focus on deciphering the FDA's
Technology Modernization Action Plan and its impact on computer system
validations. We will also discuss how to integrate modern technologies into
your compliance strategy without compromising data integrity.
Areas
covered in the session:
- Learn
how to identify “GxP” Systems
- Learn
about FDA’s current program for modernization of technology, and how this will
impact industry
- Learn
about FDA’s Technology Modernization Action Plan (TMAP), including what work is
underway and what is planned in the near term
- Discuss
the current state of Computer System Validation (CSV) approach based on FDA
requirements
- 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
- We
will discuss cloud computing and Software as a Service (SaaS) systems that can
be embraced and validated effectively
- Discuss
the best practices for documenting computer system validation efforts,
including requirements, design, development, testing and operational
maintenance procedures, including ways to improve efficiency and effectiveness
- Understand
how to maintain a system in a validated state through the system’s entire life
cycle in a more cost-effective manner.
- 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
should you attend?
As
FDA continues its technology modernization through the Technology Modernization
Action Plan (TMAP), the complexity around Computer System Validation (CSV) is
increasing. This webinar provides an invaluable guide to navigate this evolving
landscape. Grounded in the System Development Life Cycle (SDLC) Methodology,
the session offers a structured framework for planning and implementing your
validation strategy, which will withstand FDA scrutiny and assure data
integrity throughout a system's entire life cycle.
Maintaining
a system in a validated state is as vital as the initial validation. This
training program will delineate the policies, procedures, and training elements
essential for ongoing system maintenance in a validated state, mitigating any
potential risks.
In
addition, Data Integrity (DI) has come under the FDA's spotlight, especially
during inspections. Over the last decade, DI-related issues have increasingly
led to Form 483 citations and Warning Letters. This webinar will equip you with
industry best practices and the current regulatory requirements related to DI,
setting you up for successful FDA inspections.
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
Should Attend?
- 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: FDA, TMAP, CSV, Data Integrity, Compliance, Risk Management, SDLC, Technology Modernization, GxP, 21 CFR Part 11, Carolyn, Troiano, November 2023, Webinar