Overview:
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.
Electronic
records and electronic signatures (ER/ES) came into play through guidelines
established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements
for validating and documenting ER/ES capability in systems used in an
FDA-regulated environment.
Areas covered in the session:
- Learn the requirements for documenting efforts related to systems governed by FDA
- Discuss
the best practices for documenting computer system validation efforts,
including requirements, design, development, testing and operational
maintenance procedures.
- Review
examples of incorrect, incomplete, or otherwise inappropriate and non-compliant
documentation and understand why these are not acceptable
- Learn
how to prepare a procedure that will capture the best practices for FDA
compliant documentation
- Discuss
the importance of training as it relates to good documentation practices to
ensure FDA compliance
- Q&A
Why
should you attend?
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.
This
session will address the specific way of documenting your computer system
validation work to ensure it meets FDA requirements and can pass an inspection.
There are specific requirements that
must be followed in order for the Agency to consider the documentation valid,
and without following these, there is a great risk of invalidating work.
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 35 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: Good Documentation Practices, FDA, Computer, System Validation, Carolyn, Troiano, March 2023, Webinar