This webinar will assist those responsible for establishing, managing or supporting a data governance program within your organization where FDA compliance must be met. 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 attendees to the most critical and cost-effective of methods, techniques and tools available. Attendees will have a better grasp of how to leverage the best practices across all systems by creating a standardized program for data governance.
Why Should You Attend:
This webcast will discuss the importance of establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations. A data governance framework is a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data. As data governed by FDA must adhere to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable, this course will look at ways to leverage these in developing an overall data governance framework and program.
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.
You should attend this webinar 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. Examples of who will benefit from this webinar include:
Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Compliance and Audit Managers
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.
Use coupon code NB5SQH8N and get 10% off on registration.