A collection of all things process validation, this toolkit includes of IVT's Process Validation Special Edition Series, Validation Week compendiums, the "Validation Essentials" webinar, two process validation whitepapers and two validation master plans.
See the Process Validation Toolkit | More on Process Validation
Blog
Mar 4 2014 - 11:22 am
Training is a key focus of regulatory agencies, mentioned in Code of Federal Regulations Title 21 Part 211; International Conference for Harmonisation Q10, Pharmaceutical Quality Systems; and US Food...
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GXP
Feb 24 2014 - 4:32 pm
Translational research involves bringing promising candidate drugs, biologics, and medical devices from the research bench into use at the patient’s bedside. Many of the pathways taken during this...
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Article
Mar 7 2014 - 8:05 am
At IVT’s 3rd Annual Stability Testing Forum, Anu Seth illustrated the recent focus of the US Food and Drug Administration when investigating stability testing.
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Blog
Feb 21 2014 - 7:46 am
A virtual environment is a combination of hardware and software that works in tandem to simulate a real world computer infrastructure. Virtual environments function by a combination of virtual...
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JVT
Dec 17 2013 - 3:51 pm
Quality-by-design (QbD) is being used successfully for production processes; the same QbD approach can be applied to analytical procedures. QbD is “A systematic approach to development that begins...
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