Pharmaceutical Manufacturing: Process Development and Analysis Certificate

的 Pharmaceutical Manufacturing: Process Development and Analysis Certificate 在 药学院 at 亿德体育 enhances students’ understanding of the science and regulations involved in pharmaceutical manufacturing processes. 学生将学习如何制定提高产品质量的标准, 提高工厂效率, 降低生产成本, 并满足当前的国内和全球合规要求. 这个证书是学校颁发的 法规事务(RA)和质量保证(QA)研究生课程. 

的 Pharmaceutical Manufacturing: Process Development and Analysis Certificate was first launched in 2006, in response to the Food and Drug Administration’s (FDA) 2002 initiative to enhance the regulation of pharmaceutical manufacturing and product quality, 把二十一世纪的焦点放在这个机构的责任上. RA和QA研究生课程于2019年重新推出了该证书, changing it to four 课程s and renaming it the Pharmaceutical Manufacturing: Process Development and Analysis Certificate. 的 current curriculum reflects the culture of continuous manufacturing quality, such as

• the FDA’s quality metric guidance document and its focus on data integrity;
• 变更控制;
• quality risk management; and
• 安装、操作和性能合格. 

Students beg在 Certificate in Pharmaceutical Manufacturing: Process Development and Analysis with the 单位操作(5622) 课程, which reviews the steps and processes used in modern pharmaceutical manufacturing and includes hands-on workshops at a Philadelphia-based manufacturing facility, 学生们在哪里加工和加工药片. 程序的 过程监控(5629) 课程 discusses why process control is integral to quality by design (QbD) and touches upon lean and Six Sigma, 包括讨论什么时候应该或不应该应用它. 最后一门顶点课程 实验统计设计(5627), reviews statistical methods used in designing optimal processes for industry, which concludes with students designing an experimental plan to optimize a process.

调度证书

的 Pharmaceutical Manufacturing: Process Development and Analysis Certificate is only available in a traditional classroom format at the RA and QA site in Fort Washington, 宾西法尼亚. 课程 can be video-conferenced to corporate sites but are not available online.

大部分课程在周末开课, which meet all day for either six Saturdays or six Sundays every two weeks. Some Pharmaceutical Manufacturing: Process Development and Analysis Certificate 课程s are offered on weeknights. 其中一门重要的必修课， 单元操作, features two mandatory field trips to a Philadelphia-based manufacturing facility. 其中四门课可以视频会议, 学生必须参加两次制造工厂实地考察.

学习目标 

通过实践和理论方法, students will expand their knowledge of science and engineering principles with information about current regulations. 的 certificate covers best practices for process development and analysis.  

完成后，学生就会明白  

• 通过统计手段进行控制分析和制图;  

• 控制和监测;  

• 现代医药生产的单元操作;

• various ICH quality guidelines and the basic scientific principles that may influence implementation;

• fundamentals of QbD; and

• fundamentals of Six Sigma, a data-driven methodology for minimizing variability.  

接收证书, candidates must complete the required 课程s and 申请程序. 

邮政局长的证书

Students have the option to complete a post-master’s curriculum in pharmaceutical manufacturing: process development and analysis. 申请这个12学分的课程, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in bio化学, 生物学, 化学, 物理或与健康相关的学科.

Learn more about the Post-master’s 研究生 Certificate in Pharmaceutical Manufacturing: Process Development and Analysis.

程序的格式 & 课程

的 Pharmaceutical Manufacturing: Process Development and Analysis Certificate may be earned on its own or on the way to the 在RA和QA部门担任硕士.  

要获得证书, the following four 课程s must be successfully completed within a three-year period with an overall B (3.0)平均. 有三门必修课. It is suggested that students take 课程s 在 order listed below, if possible.  

• 单位操作(5622) (必须在5629年之前服用) 

• 过程监控(5629) 

• 实验统计设计(DOE) (5627)  

必须在下列选项中完成一门选修课.  

• 过程分析技术(PAT) (5625) 

• 药品生产中的微生物概念(5512)  

• 药品和医疗器械风险管理(5548) 

Students must complete any required prerequisites to pursue RA and QA graduate-level 课程s. 

All 课程s must be completed from 亿德体育’s RA and QA graduate program. 不接受其他院校的转学分. 接收证书, candidates must complete the required 课程s and 申请程序. 

Learn more about the Pharmaceutical Manufacturing: Process Development and Analysis Certificate. 

参见课程设置.

需求 

• 考生必须正式申请，按照 申请程序 (申请表格、成绩单影印本及完成通知书). 

• 在学生收到证书之前，只能完成一个证书 RA和QA MS.

• 证书必须在三年内完成.

• 接收证书, students must submit the Notice of Completion within one year of completing all required 课程work for the program.

• Students interested in pursuing the 在RA和QA部门担任硕士 may apply all credits earned from the Pharmaceutical Manufacturing: Process Development and Analysis Certificate toward their graduate degree, provided they formally apply for admission to the MS program and are accepted by 亿德体育’s 研究生院.

了解更多有关申请流程的信息. 

相关研究生学位

• 法规事务和质量保证硕士