Challenge
This international vaccines manufacturer had several site-wide instances in which employees did not follow written procedures, especially with regard to quality control. Because of an inadequate training program on Operational Procedures, its manufacturing license was revoked.

Solution
Clarkston Consulting worked with the client to overhaul the existing training program as part of a multifaceted effort to restore the manufacturer's license to produce vaccines. The new program consisted of creating reusable training modules that could be presented by process instead of individual procedures; training activities, walk-throughs, pictures, job-aids and/or process flows in each module; classes trained by experts in the relevant process to create an interactive learning environment; and an assessment process that included answering questions in the standard operating procedure (SOP) in class and during on-the-job assessments.

Benefits
With Clarkston's help, the manufacturer was able to have the license restored just six months after it was revoked, one-fourth the time it would have taken the client on its own. After reviewing the new training program, inspectors recognized it as a model program encouraging compliance in the following ways:

		The program raised participant accountability, with increased knowledge about the entire manufacturing process and an assessment at the end of each class.
		The training allowed for alterations in an efficient yet accurate manner with re-training any time an SOP changed.
		Overall, it increased program sustainability, with action plans and processes set up for the program to be maintained, managed, and improved upon for future drug production.

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