科学验证证书

The 科学研究生证书 in the 药学院 at 亿德体育 provides a strong foundation in validation principles for both experienced professionals and those seeking entry into this career field. 证书是学校颁发的 regulatory affairs (RA) and quality assurance (QA) graduate program.  

Validation science is a multidisciplinary activity that includes engineering, 化学, 微生物学, 药理学, information technology and statistics as applied to the development, 生产, 分销和监测受美国法律监管的产品.S. 食品，药品和化妆品法案. It encompasses numerous activities that are done to demonstrate and document that products, 流程和系统是可靠的, 可复制并按预期执行. 它的概念适用于广泛的活动, 比如系统, 设施, 公用事业公司, 设备, 测试方法, 流程, 数据和最终产品. The field is constantly evolving in a dynamic regulatory, economic and scientific environment. 

The certificate explores validation science in a global environment, 结合重点监管, 定义该领域的科学和分析概念. Students completing the 科学验证证书 will understand and be able to apply the benefits, 与验证科学相关的原则和概念. They will also become familiar with the domestic and international regulations governing the discipline. 

学习目标 

The Certificate in Validation Science encompasses a critical analysis of the validation field. 在顺利完成必修课程后, students pursuing the certificate will be able to understand and apply the following.  

• The purpose, benefits, basic concepts and terminology of validation science 

• 国内法规和国际法规, 指导文件, 以及与验证科学相关的标准 

• Validation principles and concepts associated with pharmaceutical, 生物技术, 医疗器械等受监管行业 

• 与设施相关的验证原则和概念, 公用事业公司, 设备, 流程, 测试方法, cleaning, 电脑化系统及产品

• Documentation necessary to support validation life-cycle activities, 包括验证主计划

• Scientific and statistical principles in the development of verification and validation requirements

邮政验证科学硕士证书

Students have the option to complete a post-master’s curriculum in validation science. This post-master’s certificate provides students with a strong foundation in validation science principles, whether the student is an experienced professional or someone seeking entry into the career field. 申请这个15学分的课程, applicants must hold a master’s degree in a pharmacy-related field and a bachelor’s degree from an accredited institution.

Learn more about the 邮政验证科学硕士证书.

程序的格式 & 课程  

The 科学验证证书 may be earned on its own or on the way to the RA和QA MS. 要获得证书, five of the following courses must be successfully completed within a four-year period with an overall B (3.0)平均.  

有两门必修课.  

• 工艺验证(5474)

• Validation of Facilities, Utilities and Equipment Validation (5468) 

选择三门选修课. 

• 统计质量控制(5451)  

• 高纯水系统(5478)  

• 无菌产品的生产(5492)

• 灭菌程序(5493)

• 计算机系统验证(5498)

• Design Control for Medical Devices and Combination Products (5503)

• 清洁验证(5516)  

• 实验统计设计(5627) 

• 过程监控(5629) 

• 专题(5650) (关注当前的验证问题) 

Students pursuing the 科学验证证书 are expected to have a knowledge of cGMPs (current good manufacturing practice regulations). 没有这些知识的学生应该考虑参加 良好生产规范(5477) 课程开始前的证书. 学生应该从证书开始 工艺验证(5474)) or Validation of FUE (Facilities, Utilities and Equipment) (5468) courses; however, those with prior educational or professional experience in validation science may begin with an elective. 

了解有关验证科学证书的更多信息.

参见课程设置.

需求 

• Participants must have a bachelor’s-level degree from an accredited institution of higher learning. 虽然没有特定的专业要求, 大多数申请人应该有医疗保健背景, 自然科学, 生物科学, 工程或相关专业.

• 所有课程必须在亿德体育完成 RA和QA研究生课程. 不接受其他院校的学分转换.

• 该证书不需要gre成绩.

• 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 may be completed before students receive the MS.

• Students should complete the certificate courses within four years. Students must apply for the 科学验证证书 within one year of completing the five courses in the program. 

• Students interested in pursuing the RA和QA MS program may apply all credits earned from the 科学验证证书 towards 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