Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates. Q. I head up the ...
As daunting as it seems, things can change. When I joined Methods Analytics, I was asked to build a data science function setting standards and best practices in the ways of working. At first, I ...
Dublin, July 05, 2021 (GLOBE NEWSWIRE) -- The "Lifecycle Management of Analytical Methods and Procedures - According to New FDA and USP Guidelines Training" conference has been added to ...
In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
A QbD and lifecycle management approach to analytical method development and qualification will result in a better understanding and fewer failures of analytical methods due to more robust methods ...
When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect. Analytical method transfer suffers from many of the same ...
Advancing analytical techniques is all well and good, but unless those advances in technology are accompanied by matching strides in technique management, the true potential of better methods may not ...
The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...
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