Lincoln, NE

Practice Area:
Manufacturing Systems - Production Control Company Profile:
Novartis Consumer Health is a manufacturer of over-the -counter pharmaceuticals in Lincoln, Nebraska and has approximately 350 employees. Novartis was looking to expand production into Class II Pharmaceuticals.

Situation:
Novartis made contact with the Nebraska MEP to find a training partner to help them become compliant with cGMP regulations in order to have their facility ready to produce Class II Pharmaceuticals. In addtion they requested help with funding for the project. The training would have to be completed within a short timeframe because production was to start early in 2001.

Solution:
The Nebraska MEP has continued to build its sources of training partners and the ability to help companies find grant funding. Through a previous Internet search for cGMP trainers the NMEP located and has used David Jones from BIZ-Tech to put on cGMP Workshops. The NMEP helped Novartis with its discussions with David Jones to arrive at the mutually agreeded training requirements and schedule. The NMEP also informed Novartis of the availablity of Nebraska Deptartment of Labor Workforce Training Grants. The NMEP aided Novartis in appling for the grant and reviewed all final documents.

Results:
Novartis was able to obtain the grant funding to help pay for the cost of the training. The cGMP training was completed in January 2001. Novartis was able to have over 50 employees trained in cGMP regulations as they apply to pharmaceutical production. The training was completed and the facility was ready for the production of the new line of pharmaceuticals to begin.

Testimonial:
Novartis is presently embarking on a new venture (Class II Pharmaceuticals) where absolute reconcilliation and traceability are key performance indicators and regulatory necessities. The training was developed to specifically address those needs. The training was effective and well received. The timing worked out well for Novartis and we consider the venture a success.