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Products Custom
Solutions here
Integrated
Training Strategy 
Situation |
Local FDA investigators had informally told a multinational firm that their training efforts would soon come under FDA review. The firm was also expecting several pre-approval audits in the coming months. The goal: enhancement of their existing training efforts, emphasizing GMP-related topics. |
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LearningPlus
Response |
LearningPlus made an initial analysis and recommended a LearningPlus baseline GMP awareness program for all personnel. The LearningPlus-designed comprehensive GMP curriculum included a two-year plan for developing and implementing the courses. The efforts focused on meeting both business and regulatory needs. LearningPlus created the programs for the firm. | ||
Outcome |
The comprehensive training plan for all personnel has been documented and is being implemented according to schedule. Assessment of personnel is starting to be conducted. The firm has records to show FDA investigators. | ||
