Development of generics: From R&D to GMP - EU edition MasterClass
15-16 February, 2023
The training aims to generate a common understanding of how to best interlink two areas and create highly efficient processes.
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..
15-16 February, 2023, Virtual
Time Zone : UTC/GMT+1 /CET
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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During more than 30 years of professional experience in the pharmaceutical industry, Helmut held senior positions in QC, 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, Quality Assurance, and as QP. 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. He has supported several companies with development projects for APIs and drug products. Additionally, he acted as a visiting lecturer at different universities teaching Drug Regulatory Affairs.
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
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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Years of experience