10 Minutes excerpt from the recorded event for your review:
Read the LinkedIn Article:
LinkedIn Article - Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
In this LinkedIn article we've encapsulated the entire session's discussions and insights.
Overview:
Ensuring
compliance with FDA regulations is paramount in the use of computer systems
within FDA-regulated environments. These systems, critical to the
manufacturing, testing, and tracking of pharmaceutical products, must adhere to
stringent data integrity, reliability, and security standards. This involves
not only understanding but rigorously applying industry best practices
throughout the vendor selection and management process to maintain systems in a
validated state, in accordance with FDA guidelines.
In
our comprehensive discussion, we will delve into various aspects of vendor
engagement, from the provisioning of hardware and software to the
implementation and ongoing maintenance of these systems. We will explore how
these systems are validated, focusing on both traditional Computer System
Validation (CSV) and the innovative approaches suggested by the FDA’s recent
guidance on Computer Software Assurance (CSA). CSA introduces a risk-based
approach to validation that emphasizes critical thinking and can be
particularly effective with modern technologies such as cloud computing and
Software-as-a-Service (SaaS).
We'll
discuss the practical tools necessary for conducting thorough audits, including
the development of audit procedures and checklists. These tools help streamline
the audit process, ensuring that vendors meet all required FDA standards.
Additionally, the session will cover the importance of incorporating risk
management into all phases of FDA-regulated activities, enhancing the
efficiency and effectiveness of system validations.
Special
attention will be given to the latest methodologies and frameworks such as
GAMP®5, Second Edition, and various software development life cycle (SDLC)
approaches including both Waterfall and Agile methodologies. These frameworks
support a comprehensive compliance strategy that helps companies navigate the
complexities of FDA regulations while leveraging the latest in technological
advancements.
By
blending traditional practices with modern strategies, this discussion will
equip participants with the knowledge to ensure their vendors deliver compliant
systems and services. This will support their efforts to maintain systems that
are not only validated but remain in a state of continuous compliance,
safeguarding the integrity of their operations and products.
Areas
covered in the session:
- Vendor
Audit
- Vendor
Questionnaire
- Audit
Procedure
- Audit
Checklist
- Leveraging
Vendors
- Vendor
Management
- FDA
GxPs
- Computer
System Validation (CSV) Methodology
- Computer
Software Assurance (CSA) Methodology
- System
Development Life Cycle (SDLC) Framework
- Critical
Thinking
- Risk
Management
- GAMP®5,
Second Edition (Good Automated Manufacturing Practice)
- Automated
Testing
- Waterfall
Methodology
- Agile
Methodology
- Compliance
Strategy
- Cloud-Based
Vendors & Validation
- Software-as-a-Service
(SaaS) Vendors & Validation
- Infrastructure-as-a-Service
(IaaS)
- Platform-as-a-Service
(PaaS)
- Cost
vs. Compliance
- SOC 2
Certification for cybersecurity
- Industry
Best Practices
- Policies
and Procedures
- Training
- Q&A
Why
you should attend:
Understanding
the nuances of auditing vendors for computer systems regulated by the FDA is
crucial for ensuring compliance and safeguarding product quality in any
FDA-regulated industry. This webinar provides an indispensable opportunity to
delve into the best practices for conducting these audits effectively. By
attending, you will gain comprehensive insights into how to assess and manage
the complexities associated with vendors who supply, implement, or maintain
computer systems critical to your operations.
You'll
explore key areas such as the importance of a solid computer system validation
strategy and how to integrate risk management into your audit processes. With a
focus on both foundational and advanced auditing techniques, including the use
of checklists and standardized procedures, this webinar will equip you with the
tools necessary to ensure your vendors adhere strictly to FDA guidelines.
Additionally,
this session will cover recent developments in regulatory expectations,
including insights into Computer Software Assurance (CSA) and its application
in modern tech environments like cloud computing and SaaS. Learning these
current and relevant approaches will empower you to adapt and enhance your
auditing strategies in a rapidly evolving regulatory landscape.
Attending
this webinar is crucial for professionals seeking to maintain rigorous
compliance with FDA regulations while managing the challenges posed by new
technologies and changing regulatory guidelines. You'll leave with the
knowledge and skills to ensure that your vendor audits effectively support the
validated and compliant status of your computer systems, an essential component
of FDA-regulated activities.
Who
should attend?
Personnel
in the following roles 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
Industries
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.
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", "vendor audit", "computer systems", "compliance", "regulatory", "CSA", "CSV", "GAMP5", "risk management", "pharmaceutical", "medical devices", "Carolyn", "Troiano", "May 2024", "Webinar"