Development of generics: From R&D to GMP - US edition MasterClass

The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products..

08-11 May, 2023, Virtual

Time Zone : Eastern Daylight Time (EDT) - UTC−04:00

Overview

The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business processes even outside the R&D or GMP areas.

R&D needs flexibility and should not be over-regulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control to work according to established and efficient procedures.

The training aims to generate a common understanding of how to best interlink these two areas and create highly efficient processes from product development to routine manufacturing of generic pharmaceutical products.

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RECOMMENDATION

Who should attend?

• Heads of R&D

• Manufacturing Heads

• Heads of QC

• Heads of QA

• Pharmaceutical Development managers

• Manufacturing managers

• Stability control managers

• QC managers

• Drug Regulatory Affairs managers

• Product Maintenance managers