🎤 Carolyn Troiano | 📅 Recording Available | 🕒 75 Minutes
We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC) phases for any IT 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 managing such a project, including “who” should be responsible for tasks, “how” the documentation should be accomplished, and “what” specific criteria will be used to define success. FDA guidelines are very specific in terms of how this is to be done.
Areas Covered in the Session :
Who Should Attend:
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: