Fundamentals and Applications of Process Chemistry (Organic Synthesis) in Pharmaceutical Development
S10412
What should be considered to understand process chemistry and establish an effective manufacturing method compliant with GMP? Efforts in the lab? Scale-down.
Lecturer Representative Director of Pharmaceutical Research and Development Consulting, Mr. Mitsuki Hashimoto Target Audience: Individuals responsible for process chemistry in pharmaceutical development facing challenges Venue: Kawasaki City Educational and Cultural Center, Room 3 [Kanagawa, Kawasaki] 12 minutes on foot from JR Kawasaki Station, 10 minutes on foot from Keikyu Kawasaki Station Date and Time: April 27, 2011 (Wednesday) 10:30 AM - 4:00 PM [Individual Consultation: 4:00 PM - 4:30 PM (Reservation required)] Capacity: 30 people *Registration will close once full. Please apply early.
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basic information
【Course Objectives and Goals】 In the process of pharmaceutical development, efficiently and cost-effectively manufacturing active pharmaceutical ingredients is crucial for winning in a competitive market. This course will clearly explain what should be considered to understand process chemistry and establish effective manufacturing methods compliant with GMP, what constitutes an efficient manufacturing method, and the challenges and solutions that companies should address, including accidents and disasters caused by failures in scale-up, all based on a fundamental understanding of process chemistry from basics to applications.
Price information
Members who apply for Tech-Zone by April 13 will receive an early bird discount price: 44,100 yen for one person (52,500 yen for two people).
Price range
P2
Delivery Time
P2
Applications/Examples of results
I. Basic Edition 1. What is Process Chemistry and Its Role 1-1 What Process Chemistry Means 1-2 The Role of Process Chemistry 2. Efforts in the Laboratory 3. Efforts in Scale-Down 4. Developments in Scale-Up 4-1 Points to Consider in Scale-Up 4-2 Troubles During Scale-Up 4-3 Troubleshooting Measures 4-4 Determining Starting Materials 4-5 What Exothermic and Runaway Reactions Are 4-6 Learning from Accident Cases 5. Measures Against Static Electricity 5-1 Examples of Static Electricity Accidents 5-2 Measures Against Static Electricity 6. GMP and Manufacturing 6-1 What GMP Is 6-2 GMP-Compliant Manufacturing 6-3 Troubleshooting Measures 7. Issues in Crystallization 7-1 Crystallization and Crystal Forms 7-2 Key Points in Crystallization 7-3 Considerations in Crystallization 7-4 Polymorphism 7-5 Issues with Polymorphism 7-6 Countermeasures for Polymorphism 7-7 Examples of Polymorphism II. Applied Edition III. Process Chemistry and Contract Manufacturing Companies 1. Points to Consider in Contract Manufacturing 2. Points to Consider in Contract Manufacturing 3. Future of Contract Manufacturing Companies IV. Trends in Pharmaceutical Companies
Company information
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