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All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR ...
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond th ...
Difficult people they are everywhere. Perhaps it's a colleague who is continually disagreeable. Or it's a subordinate who chronically complains about everything but never takes responsibility for fixing anything. Maybe it's a customer who treats you rudely as ...
The challenge here is to explain what we mean when we say cash flow. In recent decades bankers have seen several top contenders for the cash flow definitional sweepstakes—traditional cash flow, operating cash flow, and EBITDA. The ascendant definition has been ...
Layoffs are often necessary for organizations, but the days and weeks afterward determine whether your teams will quickly move forward or struggle with uncertainty. Remaining employees often feel anxiety, fear of future cuts, guilt for being “the ones who stay ...
The ability to handle crucial and difficult conversations effectively, where one is required to be mindful of one’s thoughts, emotions, impulses, words, voice, and facial expressions is crucial for Managers and Leaders. The lack of attention to one’s communica ...
This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...
Managing employee performance is a critical role for all leaders, of any group, even volunteers and family members. Expected outcomes depend on the leader’s ability to set clear performance expectations (outcomes) and in some situations help by defining metho ...