(招生中)【原料藥系列】原料藥製程開發與放大實務課程(2020年度增修版)

2020/11/14-12/19 (週六 09:30~16:30)
【適合對象】相關產業第一線工作人員或主管、需具製程相關知能之從業人員、有意投入相關領域者。
【課程規劃專家】連凌霄 副總經理(台灣神隆股份有限公司生產製造中心)
【上課時間】2020/11/14-12/19,共6週,每週六9:30-12:30 / 13:30-16:30
【總時數】36小時  
【線上報名】我要報名

【上課地點】台北市大安區復興南路一段390號11樓(大安捷運站斜對面)
*復興南路與信義路口,近師大附中及大安高工
【課程簡介】
1. Train R&D chemists and engineers in the most efficient methods for developing cheap, robust processes for the manufacture of fine organic chemicals in the minimum amount of time. And educate chemists in the principles of scale-up and development, in basic engineering concepts and in techniques for the optimisation of processes.
2. Teach the practical aspects of designing a scalable fine-chemical batch process and successfully implementing it at the kilo-lab and pilot plant scale, through an examination of the effects of unit operation theory, large-scale operating methods and equipment limitations on process safety, operability, yield, selectivity and product quality.
 
【課程大綱】(預排)
 
11/14(六)上午 Introduction
     The purpose of chemical development
     The approaches to process development
Chemical Development & Optimization
     Selecting the best route for scale-up
     Choice of raw material, reagent, solvents, etc.
     Optimizing chemical reaction
     Work-up, crystallization & product isolation
郭隆皇博士
松瑞製藥股份有限公司
製程研發部副總經理
11/14(六)下午 Analytical Issues
     In process control
     Quality control and specification setting
     Regulatory guidelines
Quality by Design & Control Strategy
Case study
11/21(六)上午 Scale-Up
     Overview of scale-up issues
     Making process robust & minimizing scale-up difficulties
Chemical Engineering Aspects
     Mass transfer & mixing
     Heat transfer & kinetics
連凌霄
台灣神隆股份有限公司
生產製造中心
副總經理
11/21(六)下午 Thermal Hazard Testing & Runaway Reactions
     Process safety consideration
     Equipment & screening approach
Process Scale-Up & Assessment
     Introduction
     Drivers for development & risk assessment
     On unit operations
11/28(六)上午 Reaction
     Scale-up of a chemical reaction
     Heat transfer & agitation in batch reactors
     Exploiting process understanding in scale-up
Reaction Quench
Color & metal removal
沈育維
台灣神隆股份有限公司
製程技術部 處長
11/28(六)下午 Extraction
     Liquid-liquid extraction
     Scale-up of extraction processes
Distillation & Stripping
     Vapor-liquid equilibrium diagram
     Scale-up of distillation process
Case study
12/5(六)上午 Crystallization & Precipitation
     Basic principle
     Controlling supersaturation
     Batch crystallization scale-up and issues
Case study
連凌霄
台灣神隆股份有限公司
生產製造中心
副總經理
12/5(六)下午 Product Isolation & Drying
     Background & principles
     Filtration & drying equipment
     Scale-up & trouble-shooting
Milling Operations
     Type of milling & milling equipment
     Milling operations & scale-up
12/12(六)上午 New Technologies - Continuous Flow Process
     Introduction of continuous flow process
     The fundamental mechanism of mass & heat transfer in flow reactors
     Process R&D and scale-up of continuous flow process
     The shift from batch to flow process development
     Process analytical technology (PAT)
楊立勔博士
瑞林科技顧問公司副總經理
   
江佩珍
台灣康寧研發中心資深研究員
12/12(六)下午 Peptide Process Development
     Introduction of peptide products
     Synthetic strategy
     Peptide process development - synthesis, purification, lyophilization
     Analytics
莊宏偉
台灣神隆股份有限公司
製程研發中心計畫主任
12/19(六)上午 Column chromatography
     Design of chromatographic process
     Scale-up of chromatographic process
     Operational aspects and economics
Lyophilization
     Basic concept & process
     Lyo cycle development
     Scale-up of lyophilization process & process control
沈育維
台灣神隆股份有限公司
製程技術部處長
12/19(六)下午 Kilo Lab & Pilot Plant Manufacturing
     Facility design
     Equipment
     Operating principles & regulatory drivers
 Summary
 
【上課時間】2020/11/14-12/19,共6週,每週六9:30-12:30 / 13:30-16:30
【總時數】36小時
【上課地點】台北市大安區復興南路一段390號11樓(大安捷運站斜對面)
復興南路與信義路口
【課程費用】協會團體會員NT$21,600;非團體會員NT$23,400。
  • 10/30前完成繳費 可享 早鳥優惠價每人NT$ 19,800
  • 同公司2人以上同行,每人只要NT$ 19,800
  • 原料藥班之結訓學員 (舊生).報名今年度課程,每人只要NT$ 12,000 (限額4人)
【線上報名】我要報名
【諮詢專線】02-77003883 分機11或 分機12 歡迎來電
(注意事項:以上課綱及開課日期/授課師資/場地..等;本協會保有異動權,如有變動將會提前通知)