Live Webinar Good Documentation Practices for FDA-Regulated Computer System Validation

12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Hear By 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"

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Description

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 webinar on computer system validation regulated by FDA, describes the basic requirements for validating and documenting ER/ES capability in systems.

Why Should You Attend

You should attend this webinar training on computer system validation regulated by FDA, if you are responsible for planning, executing or managing the validation of a system. This is true whether using a "wet" or ink-based signature, or an electronic signature. It is also true whether maintaining paper-based or electronic records. Different requirements pertain to each type of signature or record, and there is a specific set of best practices that need to be followed for either type.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized

Areas Covered

--   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

Who will Benefit

--    Information Technology Analysts
--    QC/QA Managers and Analysts
--    Clinical Data Managers and Scientists
--    Analytical Chemists
--    Compliance Managers
--    Lab Managers
--    Automation Analysts
--    Computer System Validation Specialists
--    GMP Training Specialists
--    Business Stakeholders
--    Consultants in the Life Sciences Industry

Industries who can attend

Learning Objectives

Get an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements
Understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs
Get a good grasp of how to leverage these practices across all systems by creating a standardized program


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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