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Products Custom
Solutions here
On-The-Job
Training 
Situation |
A U.S. pharmaceutical firm, under an FDA-imposed consent decree, needed to create and implement a program for investigating and documenting deviations. |
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LearningPlus
Response |
LearningPlus developed the firm's initial policy and corporate operating procedure, as well as a seven-hour workshop, with instructional materials, on conducting failure investigations. The program was implemented at the firm's sites in the U.S., Canada, and Puerto Rico. LearningPlus trained nearly 1,000 personnel and then developed a train-the-trainer program so the firm could continue the efforts internally. | ||
Outcome |
Using the training, workbooks, and checklists, the firm successfully determined the cause of several deviations whose cause had previously eluded them. The firm identified and put in place solutions to prevent the problems from recurring. FDA investigators reviewed the program and results from various investigations, and found the results to be satisfactory. | ||
