Communication Presentation Process Improvement 
Blog: Ask a Student Pharmacist
AUGUST 22, 2024
Doctoral Capstone Presentations pbhamidi Thu, 08/22/2024 - 13:28 Blending Scientific Knowledge of the Human Body, Mind, Emotions and Spirit Doctoral Capstone Presentations Below are links to the brief presentations of doctoral capstone projects. Interested in working with an OTD capstone student or exploring the possibility?
ISPE
MARCH 29, 2023
[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,
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ISPE
MARCH 29, 2023
[link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g.,
ISPE
OCTOBER 27, 2022
Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5. The recent expansion of global oligo manufacturing demand has presented numerous opportunities to design better molecules, better processes, and better facilities.
ISPE
AUGUST 30, 2022
Case studies are presented that demonstrate the importance of defining the raw material attributes that are critical to product quality and how this could support increased postapproval flexibility (including the use of ICH Q12 principles). Present in sufficient quantity to achieve target concentration in process and enable defoaming.
ISPE
AUGUST 29, 2022
Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. You may unsubscribe from these ISPE communications at any time.
ISPE
SEPTEMBER 11, 2023
This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. Nature Communications 12, no. Biotechnology Progress 36, no.
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