This bundle of webinars will help you to understand the steps needed to transfer, validate and maintain an automated assay in the laboratory, heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms, the TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligatio..
The objective of this bundled Webinar is to teach participants how to develop their domestic and international strategies for effective reimbursement in parallel to achieving Regulatory Approval, to learn the proper way to set up for a Regulatory Inspection, understand in detail the new requirements for labeling from FDA and EMA, Generation of Controlled Documents and Related Training and will also review t..
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..