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Recorded Webinar
Achieving the lifecycle approach to process validation with QbD, RTR and PAT
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
The authorities have increased the requirements for product related risk analyses and know-how about the chemistry in the manufacturing process, as part of the approval process. It has to be an intergraded part in all pharmaceutical projects. A harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science The concept is that quality should be built into a product with a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.
Move from regulatory guidance to scientific guidance, this workshop will teach you about:
- Understanding the principles of QbD in relation to PV
- Reviewing ICH guidelines Q8 and Q9 and implementing ICH Q10 to ensure quality for continuous improvement of process
- Implementing QbD as a mechanism for helping process work correctly and efficiently
- Assessing the need for numerous runs under QbD and the new PV guidance
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