10 Minutes excerpt from the recorded event for your review:
Best Practices in Preparation for an FDA Computer System Audit
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Overview:
The
FDA mandates that all computer systems used to produce, manage, and report on
“GxP” (GMP, GLC, and GCP) related products be validated and maintained per
specific guidelines. Since the 1980s, when the FDA first issued its guidance on
computerized systems, the emphasis on computer system validation (CSV) has
grown, reflecting the increasing complexity and criticality of these systems in
regulated industries. This webinar will provide an in-depth understanding of
the FDA’s current stance on validated computer systems subject to inspection
and audit, highlighting areas of heightened scrutiny, particularly higher-risk
systems.
The
FDA’s guidance on computerized systems, initially issued in 1983, has evolved
significantly. Initially focusing on pharmaceuticals, the guidance was expanded
to include medical devices. A major development was the introduction of 21 CFR
Part 11 in 1997, which established standards for electronic records and
electronic signatures, paving the way for a paperless environment while
ensuring data integrity and security. This regulation has been periodically
updated to balance compliance costs with industry needs, incorporating
discretionary enforcement measures to facilitate technological adoption without
imposing excessive regulatory burdens.
In
response to rising industry findings, the FDA issued additional guidance on
Data Integrity in late 2018, addressing critical issues and promoting best
practices to ensure inspection readiness. More recently, in September 2022, the
FDA released draft guidance for Computer Software Assurance (CSA). Unlike the
traditional, document-driven CSV approach, CSA emphasizes critical thinking and
risk assessment. This shift aligns with the latest GAMP®5, 2nd Edition,
published in July 2022, which supports non-linear software development
methodologies, including Agile.
This
webinar will also cover the validation of modern systems such as cloud-based
services and Software-as-a-Service (SaaS) solutions, as well as automated
testing techniques. Participants will gain insights into current compliance and
enforcement trends influenced by technological advancements, ensuring their
companies remain in a state of inspection readiness.
By
understanding the evolution of FDA computer system audits, from their inception
to the present day, participants will be better equipped to handle these
challenges, ensuring their systems are audit-ready and compliant with current
FDA expectations
Areas
covered during the session:
- Computer
System Validation (CSV) and the System Development Life Cycle (SDLC)
Methodology
- Computer
Software Assurance (CSA), Draft Guidance from FDA issued September 2022
- GAMP®5,
2nd Edition, published by ISPE in July 2022, and alignment with CSA
- Waterfall
and Agile, as Software Development, Testing, and Release Life Cycle
Methodologies
- “GxP”
– Good Manufacturing, Laboratory and Clinical Practices
- 21
CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data
Integrity and the “ALCOA+” Principles (attributable, legible, contemporaneous,
original or “true copy,” accurate, complete, consistent, enduring, and
available)
- Data
Archival and Governance to ensure security, integrity and compliance
- Validation
Strategy that will take into account the system risk assessment and system
categorization (GAMP®5) processes
- Recent
FDA findings and citations for companies in regulated industries
- The resources, documentation and room preparation necessary to adequately prepare for FDA inspection
- Q&A
Why
you should attend?
Attending
this webinar is critical for ensuring your organization's computer systems meet
FDA audit requirements and are prepared for inspection. The session will
provide detailed insights into maintaining compliance with FDA guidelines,
which is essential for avoiding costly regulatory issues and ensuring smooth
operational processes.
You
will gain a thorough understanding of the latest FDA expectations and how to
apply them effectively within your organization. This includes learning about
current trends in compliance and enforcement, which are influenced by
technological advancements. The webinar will cover best practices for
validating modern systems like cloud-based services and Software-as-a-Service
(SaaS) solutions, ensuring these technologies are implemented and maintained
according to FDA standards.
Additionally,
the session will highlight practical strategies for maintaining data integrity
and security—critical aspects of FDA audits. By understanding and implementing
these best practices, you can ensure your systems are not only compliant but
also robust against potential data integrity issues.
Ultimately, this webinar will equip you with the knowledge and tools necessary to position your company in a state of inspection readiness, safeguarding your operations and enhancing your compliance strategies. This proactive approach is vital for staying ahead in the ever-evolving regulatory landscape and ensuring the continued success and reliability of your FDA-regulated systems.
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.