2014 - Best Practices for Documenting a Computer System Validation Process

Instructor: Carolyn Troiano
Description:
We will discuss the importance of applying industry best practices when documenting the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
This course will describe the best practices for documenting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done. In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.
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 disemminated 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.
Why Should you Attend:
You should attend this seminar if you are responsible for planning, executing or managing the validation of a system governed by FDA regulations. 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. There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available for appropriate documentation of the validation process.
Objectives of the Presentation:
Upon completion of this session, attendees will have 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. They will 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. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program.
Who can Benefit:
This webinar will benefit any Consultants working in the Life Sciences Industry who are involved in Computer System Implementation, Validation and Compliance.
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 and Individuals who are responsible for Computer System Validation Planning, Execution, Reporting, Compliance and Audit.
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