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.
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.
Areas Covered in this Webinar:
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
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
Who Will Benefit:
Information Technology Analysts
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Computer System Validation Specialists
GMP Training Specialists
Consultants in the Life Sciences Industry
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.
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