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Optimizing Tech Transfer and GMP Compliance                             

 

Situation

 

A large consumer health firm wanted to speed up its product development cycle with an emphasis on meeting GMPs and reducing the need to redo work that didn't meet FDA expectations. Their question: how could attention to training and human performance help them attain their goal?

 
LearningPlus Response
  LearningPlus adapted one of its existing programs to meet the special needs of development personnel. It helped the firm articulate its vision of quality system elements that begin in the earliest stages of development and mesh with GMP requirements. Training programs have been developed for all development and support personnel.
 

Outcome

  The project is continuing with more focused training on particular quality system elements. An assessment method will be implemented to determine the effectiveness of the training activities.
 
   

 

 
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