无菌过程制造证书

无菌过程制造证书药学院 at 威尼斯赌场网站 focuses specifically on the regulations and quality processes that are unique to sterile products. 这个证书是学校颁发的 regulatory affairs (RA) and quality assurance (QA) graduate program 可以在网上找到. A master’s degree is not required to earn this certificate.

课程 explore the routes and types of sterile product administration, manufacturing and facility requirements for their design and production, 以及验证和遵从性需求. Attention is also focused on the technical and regulatory aspects of sterilization processes, 包括热, 气体, 辐射, 过滤和无菌处理方法.

邮政局长的证书

Students have the option to complete a post-master’s curriculum in sterile process manufacturing. Students study the techniques and applicable regulations used 在 development and manufacture of sterile products. 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 Sterile Process Manufacturing.

Regulatory Affairs and Quality Assurance at the 药学院 

50多年来,威尼斯赌场网站 药学院 提供了优秀的研究生课程 RA和QA

药学院  

  • 1968年开创了RA和QA研究生教育, offered the first RA和QA online degree program and offers the most comprehensive RA和QA curriculum;   

  • 拥有来自工业界和美国的优秀专家教师.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught; 

  • 吸引了来自生物制药的学生, 医疗设备, 医药及相关行业(化妆品), 食品和保健); 

  • schedules live courses with interactive discussions and workshops on evenings and weekends; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • 为学生提供个性化服务.    

Certificates provide credentials from Temple’s well-respected RA和QA graduate program, 哪些可以适用于RA和QA硕士学位. 

程序的格式 & 课程

的 无菌过程制造证书 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 courses must be completed within a three-year period with an overall B (3.0)平均. 

学生完成两门必修课程.

  • Microbiological Concepts in Pharmaceutical Manufacturing (5512) 

  • 无菌产品的生产(5492) or 灭菌程序(5493)  

下列课程中的两门选修课. 

  • 统计质量控制(5451) 

  • 无菌产品的生产(5492)  

  • 灭菌程序(5493)

  • 无菌产品的开发(5501)

  • 疫苗:RA和QA问题(5572) 

It is suggested that students take at least one of the required courses before pursuing other courses 在 certificate. 的 remaining courses may be taken in any order, and many courses are available on the weekends.

To receive the certificate, candidates must complete the required courses and application procedures. 的 certificate is open to students with bachelor’s degrees 在 sciences. 

All courses must be completed from the 药学院’s RA和QA研究生课程.

不接受其他院校的转学分. If a student has taken an identical course at an accredited U.S. 研究生院, the student may petition the RA和QA program to waive that requirement and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate.

Learn more about the Sterile Process Manufacturing Certificate.

参见课程设置.

需求 

  • To be considered for the 无菌过程制造证书, candidates must have a degree from an accredited institution of higher learning. (A degree in science or engineering is suggested but not mandatory.) 

  • All courses must be completed from 威尼斯赌场网站’s RA和QA研究生课程. 不接受其他院校的转学分. If a student has completed an identical course at an accredited U.S. 研究生院, the student may petition the RA和QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

  • Candidates must formally apply and follow the application procedures (application form, 成绩单及完成通知书影印本). 

  • Only one certificate program may be completed before students receive the RA和QA MS. 

  • 证书必须在三年内完成. Students must apply for the certificate no more than one year after completing the course requirements. 

  • Students interested in pursuing the RA和QA MS degree may apply all credits earned 在 Certificate in Sterile Process Manufacturing towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by 威尼斯赌场网站’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

学费 & 费用

In keeping with Temple’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

学费是一样的, 课程是否在线, 校园, part of a certificate program or part of another master’s program at the 药学院.

宾夕法尼亚居民的课程: $3,393
非居民每门课: $4,218

学费 rates at 威尼斯赌场网站 are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), 课程负荷(全日制或非全日制), 居住在州内或州外, 和更多的.

你可以看到完整的 Cost of Attendance breakdown on the Student Financial Services website.

认证

威尼斯赌场网站’s departments and programs are accredited by the 中部州高等教育委员会.

PH-SPM-GRAD