Success stories

During her career at Schering AG Dr. Unger-Bady has successfully built up and led a department at the interface of Regulatory Affairs and Product Supply managing 16 000 variations per year at an international level. The department worked under total quality management aspects thus being highly efficient and fit for GMP inspection.

The regulatory database, which had been designed, implemented and trained by her, was fully validated according to CFR, Part 11. The regulatory data captured within this IT system automatically revealed the regulatory data for all Product Quality Reviews and delivered the regulatory basis for the release of product within Product Supply.

Selected Examples:

-this section is currently under construction-


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					Success stories During her career at Schering AG Dr. Unger-Bady has successfully built up and led a department at the interface of Regulatory Affairs and Product Supply managing 16 000 variations per year at an international level. The department worked under total quality management aspects thus being highly efficient and fit for GMP inspection. The regulatory database, which had been designed, implemented and trained by her, was fully validated according to CFR, Part 11. The regulatory data captured within this IT system automatically revealed the regulatory data for all Product Quality Reviews and delivered the regulatory basis for the release of product within Product Supply. Selected Examples: -this section is currently under construction-