This lecture-based, 3-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing Practices (cGMPs), regulatory compliance, and maintaining a culture of quality …
In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the Pre-Investigational New Drug (IND) meeting with FDA. Understanding how to navigate initial …
In the early stages of the pharmaceutical drug approval process, it is essential to maximize outcomes of the Pre-Investigational New Drug (IND) meeting with FDA. Understanding how to navigate initial …
Current Good Manufacturing Practices (cGMPs) in a regulated industry require the use of controlled documents. Participants in this course will learn strategies for designing and writing controlled documents, with the …
This course will outline the CAPA system; the tools used to identify the root cause of deviations, methods used for root cause analysis, and the processes for Corrective Action and …
This lecture-based, 2.5-hour live webinar covers the FDA’s current Good Laboratory Practice (cGLPs) regulations and how they affect the conduct of nonclinical laboratory safety studies. This course introduces the various …
The FDA regulates both finished dietary supplements and dietary ingredients to ensure they are appropriately labeled, and safe for the consumer. Described in 21 CFR 111, these regulations provide for …
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