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Training 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.

Key Takeaways:

  • What are the specific challenges connected with development of Generic Pharmaceutical products?
  • Understand the concept of Quality by Design development
  • How should bioequivalence and comparability studies be designed?
  • Introduction to the procedures to obtain Marketing Authorisations in the EU
  • What are the different levels of detail in CMC versus GMP documentation?
  • How will upcoming guidelines impact our business?

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

Trainer

Dr. Helmut Vigenschow
Dr. Helmut VigenschowSenior pharmaceutical consultant and founder of ViPharmaService

Download the Agenda

Download detailed Agenda - Development of generics: From R&D to GMP MasterClass