医药制造:工艺开发和分析证书
The 医药制造:工艺开发和分析证书 in the School of Pharmacy 在亿德体育，该课程旨在加强学生对药物生产过程中涉及的科学和法规的理解. Students will learn how to set standards for increasing product quality, improving plant efficiency, lowering production costs, and meeting current domestic and global compliance requirements. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program.
制药生产:工艺开发和分析证书于2006年首次推出, 为了响应食品和药物管理局(FDA) 2002年提出的加强药品生产和产品质量监管的倡议, bringing a 21st-century focus to this agency responsibility. The RA and QA graduate program relaunched the certificate in 2019, 将其改为四门课程，并更名为“制药制造:工艺开发与分析证书”. 目前的课程反映了持续制造质量的文化，例如
- FDA的质量度量指导文件及其对数据完整性的关注;
- change control;
- quality risk management; and
- installation, operational and performance qualifications.
学生开始在制药证书:过程开发和分析与 Unit Operations (5622) course, 它回顾了现代制药生产中使用的步骤和过程，并包括在费城制造工厂的实践讲习班, where students mill and process tablets. The program’s Process Monitoring (5629) 课程讨论了为什么过程控制是设计质量(QbD)的组成部分，并涉及到精益和六西格玛, including discussions on when it should or should not be applied. The final capstone course, Statistical Design of Experiments (5627), 回顾了统计方法在设计工业优化过程中的应用, 最后让学生设计一个实验计划来优化一个过程.
Scheduling the Certificate
药物制造:过程开发和分析证书仅在华盛顿堡的RA和QA站点以传统的课堂形式提供, Pennsylvania. 课程可以通过视频会议传到企业网站，但不能在网上提供.
The majority of courses are offered on weekends, 每两周有六个星期六或六个星期日全天开会. 一些制药业:工艺开发和分析证书课程在工作日晚上提供. One of the key required courses, Unit Operations其中包括两次强制性的实地考察，前往费城的一家制造工厂. While four of the classes can be video-conferenced, students must participate in the two manufacturing facility field trips.
Learning Objectives
Through hands-on and theoretical approaches, 学生将通过了解现行法规扩展他们的科学和工程原理知识. 该证书涵盖了过程开发和分析的最佳实践.
Upon completion, students will understand
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control analysis and charting via statistical means;
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control and monitoring;
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unit operations of modern pharmaceutical manufacturing;
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可能影响实施的各种非物质物质质量指南和基本科学原则;
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fundamentals of QbD; and
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六西格玛的基本原理，一种数据驱动的最小化可变性的方法.
要获得证书，考生必须完成规定的课程和申请程序.
Post-master’s Certificate
学生可以选择完成制药制造的硕士后课程:工艺开发和分析. To apply for this 12-credit program, 申请人必须持有药学相关领域的硕士学位和生物化学学士学位, biology, chemistry, physics or a health-related discipline.
Program Format & Curriculum
《亿德体育》可以自己获得，也可以在获得证书的过程中获得 MS in RA and QA.
To earn the certificate, 以下四门课程必须在三年内顺利完成，总成绩为B (3).0) average. There are three required courses. 如果可能的话，建议学生按照以下顺序学习课程.
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Unit Operations (5622) (must be taken prior to 5629)
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Process Monitoring (5629)
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Statistical Design of Experiments (DOE) (5627)
One elective must be completed from the following choices.
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Process Analytical Technology (PAT) (5625)
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Microbiological Concepts in Pharmaceutical Manufacturing (5512)
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Risk Management for Pharmaceuticals and Medical Devices (5548)
学生必须完成任何必要的先决条件，以追求RA和QA研究生水平的课程.
所有课程必须完成亿德体育的RA和QA研究生课程. No transfer credits from other institutions are accepted. 要获得证书，考生必须完成规定的课程和申请程序.
Requirements
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Candidates must formally apply, following the application procedures (application form, photocopies of transcripts and Notice of Completion).
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Only one certificate may be completed before students receive the RA and QA MS.
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The certificate must be completed within three years.
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To receive the certificate, 学生必须在完成所有必修课程的一年内提交结业通知书.
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有兴趣攻读RA和QA硕士学位的学生可以将药学制造:工艺开发和分析证书的所有学分用于研究生学位, 前提是他们正式申请硕士课程并被亿德体育录取 graduate school.
Learn more about the application process.