Type of Business Pharmaceutical manufacturer
Revenue: $1.5 billion
The Challenge: The FDA requires notification for any changes to the manufacturing process for pharmaceuticals. The company's internal approval process for FDA notification took 30 days, required extensive effort from key resources, and many requests for improvement changes were rejected due to the effort required in the approval process. The result was that needed cost savings improvements were delayed or not made at all.
The Goal: Streamline the FDA notification process to reduce the amount of time and effort required, thus enabling the implementation of more cost savings improvements.
The Process: Consultant conducted a one-week Kaizen blitz event with key process experts and FDA representation.
Results: The notification process was successfully reduced from 30 days to 2 days.
Duration: One week of preparation and one week for event.
Consultant's Role: Planned and facilitated the Kaizen blitz event.
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