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Products Custom
Solutions here
Moving
from a Research to a GMP Organization 
Situation |
A small New England biotechnology firm was in the process of starting Phase III clinical trials and developing their manufacturing operation. Their goal: establish a GMP vision in its personnel and implement a GMP Quality System. |
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LearningPlus
Response |
Since most personnel had a very limited GMP background, LearningPlus presented a series of GMP workshops on basic and advanced GMPs, procedure writing and record keeping, and basic validation. | ||
Outcome |
The firm has implemented quality systems and is in the process of submitting their first NDA. | ||
