Achieve Reliable Process Technology Transfer With Fundamental Process Understanding
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- 28/01/2021 - 11:00 am - 11:45 am CST
Pharma processes are among the more complex processes in the chemical industry. Over the past decade or so, the traditional “quality-by-testing” approach of trial-and-error is being consciously replaced, partly or fully, by a more scientific approach across all aspects of pharmaceutical engineering – discovery, development and manufacturing. This “Quality by Design (QbD)” paradigm – which is a risk and fundamentals based approach to process development and transfer – makes it imperative that the entire development lifecycle be carried out in a systematic, science-based and quality risk-driven manner, so that the quality of the final product is no longer left to chance.
The central tenet of QbD is “process understanding” – a term used by the US FDA to describe the degree of knowledge that an organization has acquired on its product and the pertinent manufacturing processes. Process understanding is not a “nice-to-have”. It is actually critical to achieve a state of operations where things are done right the first time, every time. In fact, with good process understanding, an organization stands to reap a number of impactful business benefits such as reduced time to market, better use of resources, elimination of wastage and perhaps most importantly, a no-surprises path to regulatory approval.
In this webinar (the first of a series), we will show how science-driven analysis and data-driven modeling can be combined to develop a systematic and economically feasible workflow to get process technology transfer right first time, every time.
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Achieve Reliable Process Technology Transfer With Fundamental Process Understanding
28/1/202111:00am CST45 minutesPharma processes are among the more complex processes in the chemical industry. Over the past decade or so, the traditional “quality-by-testing” approach of trial-and-error is being consciously replaced, partly or fully, by a more scientific approach across.
In this webinar (the first of a series), we will show how science-driven analysis and data-driven modeling can be combined to develop a systematic and economically feasible workflow to get process technology transfer right first time, every time.
