Good Documentation Practices to Support FDA Computer System Validation
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 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
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
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
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
Speaker Profile :
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.