FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries have been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identif..
In this bundled webinar instructors will describe the importance of classifying computer systems subject to FDA regulations in accordance with GAMP, the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes, also about FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and ..
This webinar bundle is ideal for all FDA regulated industries. These webinars will help attendees understand the fundamental steps of deviation investigation with a focus on using facts and objective evidence to arrive at root cause and CAPA. They also focus on how to avoid the pitfalls the mat occur during FDA investigations and help eliminate 482 observations. These courses will help you construct and mai..