Upon completion of this session, attendees will have an understanding of
FDA compliance and enforcement as it relates to computer system
validation. They will understand how to develop the most robust computer
system validation compliance program, focusing on the critical areas of
interest to FDA.
The attendees will have a good grasp of how to
identify potential weaknesses and findings, as well as how to make
recommendations for addressing and remediating them through risk
In particular, we will focus on best practices for
validating computer systems regulated by FDA and meeting compliance with
electronic records and electronic signatures (21 CFR Part 11). We will
also provide current FDA trends, including a focus on data integrity
issues in industry, which will be illustrated through industry examples.
webinar will cover what you need to do to prepare for an FDA audit, and
also the importance and steps required to be certain you have audited
all vendors of regulated systems appropriately.
Why you should attend
and compliant computer system validation is critical to any
FDA-regulated organization. FDA has set forth very specific requirements
for meeting compliance, and a very prescriptive set of enforcement
actions to protect patient and/or consumer safety. This course will
enable you to best anticipate and prepare for FDA scrutiny, understand
your role during inspections and audits, and gain insight to the level
of enforcement associated with various findings, consent decrees and
warning letters. Examples from industry will be used as case studies to
It is vital for regulated companies to maintain
a pulse on the regulatory environment in order to fortify system
validation efforts, as necessary, to meet FDA expectations. It is the
best practice to have a robust computer system validation, continue
executing against it consistently, and documenting it thoroughly. By
maintaining a strong and consistent computer system validation program,
companies can further build trust with FDA and the consumers who rely on
such oversight for protection.
Who Will Benefit
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns working at the companies listed above
students attending schools and studying computer system validation,
regulatory affairs/matters (related to FDA) or any other discipline that
involves adherence to FDA regulatory requirements
Carolyn (McKillop) Troiano has
more than 35 years of experience in the tobacco, pharmaceutical, medical
device and other FDA-regulated industries. She has worked directly, or
on a consulting basis, for many of the larger pharmaceutical and tobacco
companies in the US and Europe, developing and executing compliance
strategies and programs. Carolyn is currently active in the Association
of Information Technology Professionals (AITP), and Project Management
Institute (PMI) chapters in the Richmond, VA area.
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.
Time: 08:00 AM PST | 11:00 AM EST
- FDA Regulatory Oversight
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- GAMP 5 Software Categorization
- System Risk Assessment
- Requirements, Design, Testing
- Requirements Traceability Matrix (RTM)
- Validation Documentation
- 21 CFR Part 11 Compliance (Electronic Records/Signatures)
- Audit Preparation
- Most Common Problems
- Best Practices
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