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.
- 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