Development of generics: From R&D to GMP - US edition MasterClass
08-11 May, 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..
08-11 May, 2023, Virtual
Time Zone : Eastern Daylight Time (EDT) - UTC−04:00
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.
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RECOMMENDATION
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
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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