pharma packaging
pharma packaging
pharma packaging

Some of the hot topics

The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environments and the functional priorities is a key success factor. Conflicts, mostly resulting from different approaches and priorities, can have a 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.

Benefits of In-house Trainings

Get to know the Trainer

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

During more than 30 years of professional experience in thepharmaceutical industry, Helmut held senior positions inQC,Project Management, Regulatory Affairs,Pharmaceutical Development and Quality Assurance. He worked for 3 years in India to set up a pharmaceutical development center for ratiopharm GmbH as a greenfield project. Since 2016 he is supporting the pharmaceutical industry as an independent consultant in the areas of Drug Regulatory Affairs and Quality Assurance. Due to his in-depth experience in R&D as well as the GMP area, he perfectly knows the challenges and opportunities at the interface between these fields. Additionally, he acts as a visiting lecturer at different universities teaching Drug Regulatory Affairs.

Feel free to suggest the topics that you would like to learn about at
our Development of generics: From R&D to GMP In-house Training.

Request an Offer

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

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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