美国药典法定方法验证.pdf

U.S. PHARMACOPEIA
U
The Standard of Quality
美国典专业培训
Invitation邀请函
美国药典委员会中华区总部诚地邀请恐参加将在亩京举办的药典培训课程。
Usp-china sincerely invites you to attend the USP Pharmacopeial Education combined
courses to be offered in Nanjing.
Validation of Compendial Procedures
美国药典法定方法验证
时间/地点Time/ Location
授课时间Time
授课地点 Location
月25日Nov.25,2009
南京 Nanjing
详细培训地址请见第2页
Remarks Please find the venue details in page 2
参加对象 Who Should attend:
该课稈由关国药典委员会特聘专家现场讲授。通过全面阐述美国约典通则<1225>方法验证要求,听众将了解如何应用
方法验证性能参数、学习开发验证方案、使用统计学方法评佔数据,同时还将了解方法验证与方法确认的区别以及替
代方法的验证要求。
Gain insight into USPS perspective on validating methods as detailed in General Chapters<1225>. The audiences will
learn how to apply specific validation performance parameters, develop protocols, and use statistics to evaluate the
data. The distinctions between verification and validation will be reviewed and the requirements for validation of
alternative methods wil be addressed
参加对象 Who Should attend
制药及相关行业中的实验室科学家、实验室经理和实验员,执行方法验证的化学师及科研人员。
Laboratory scientists, lab managers, and quality and compliance staff in the pharmaceutical and allied industries, and
scientists, chemists and those who perform validation procedure
讲师 Instructor
杨仲元教授,美国药典国际健康专家委员会委员,USP药典培训特興专家(讲师介绍请见第2页)
Professor Yang Zhong-yuan, member of USP Expert Committee of International Health(2005-2010), the USP
Professional Education Faculty. please refer to page 2 for details)
若您希望报名参加培训,请登录wwW,uSp,org/ZH/ education在“课程”项下进行网上报名,或填写报名表并
于截止日(11月17日)前发送至 span@usp.orq或传真至(86)21-51370610
For registration, please visit above mentioned website for online registration, or ill out the REGISTRATION FORM and
RSVP before the deadline (Nov. 17)
美国药典中华区总部USP- hina
海市张江高科技园区李冰路67弄11号楼(201203
Bld. 11, Lane 67, Libing Rd, Zhangjiang Hi-tech Park, Shanghai, 201203, China
Tel!:(86)21-51370600ext.8896/8898/8899,Fax:(86)21-51370610
E-mail: uspcn(@usp. org, Website: ww.usp. org.
The Standard of Quality El Standar de Calidad Der Qualitatsstandard La Norme de Qualite质量标准る-ss,a