FDA Compliance and GAMP V Computer System Classification

$299.00

Description:

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP5. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.

Areas to be Covered:

Gain an understanding of GAMP V computer system classifications
Develop the ability to apply GAMP V in classifying computer systems in your organization
Understand the level of computer system validation required, based on the classification as determined using GAMP V
Discuss the best practices necessary to ensure all systems are classified properly and validated appropriately
Learn how to develop the appropriate computer validation strategy, including the level of testing required for the given computer system classification, as determined by GAMP V
Understand how to effectively document the process of computer system classification and how to maintain current information about the various systems in your organization and how they are validated
Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
Understand the level of training required for the various GAMP V computer system classifications, and the skills and expertise necessary to make the classification determination
Industry Best Practices

Who will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Compliance and Audit Managers
Laboratory Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers
Consultants

Carolyn Troiano

Carolyn Troiano has more than 30 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.

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.