Development of generics: From R&D to GMP In-house Training

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.

EVENT INTRODUCTION

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.

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

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Risk-Based Validation of Laboratory Computerised Systems In-house Training
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Past Clients

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The level of professionalism of the trainer. Fine-tuned program without wasting time

Managing Director – European pharma company

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Clear and interesting way of presenting issues, good examples and very knowledgeable trainer.

HR Director - Multinational company based in Europe

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Excellent trainer, super skilled, funny and extremely dynamic

M&A Professional

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This training was interesting and I would love to attend more trainings like this.

HR Professional

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All lectures of the trainer was exactly what I was looking for and it was directly related to my experties and area that I am working. On top of that he prepared all lectures in a very practical way and also took his time to asnwers to the questions and he made sure that we got the asnwer. The organization of this class was also very good.

Pharmaceutical professional

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Comprehensive overview with very knowledgeable and experienced trainers. The break-out sessions were great as they made the course more interactive and allowed us to apply the concepts in practice.

Banking professional from Europe

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