美国FDA验证高级培训 .pptx

;目录Table Of Contents;;What is Validation?;Validation;Validation Is.....;To Consistently Produce A Desired Known Product;9、我们的市场行为主要的导向因素，第一个是市场需求的导向，第二个是技术进步的导向，第三大导向是竞争对手的行为导向。七月-21七月-21Sunday, July 18, 2021 10、市场销售中最重要的字就是“问”。14:11:3114:11:3114:117/18/2021 2:11:31 PM 11、现今，每个人都在谈论着创意，坦白讲，我害怕我们会假创意之名犯下一切过失。七月-2114:11:3114:11Jul-2118-Jul-21 12、在购买时，你可以用任何语言；但在销售时，你必须使用购买者的语言。14:11:3114:11:3114:11Sunday, July 18, 2021 13、He who seize the right moment, is the right man.谁把握机遇，谁就心想事成。七月-21七月-2114:11:3114:11:31July 18, 2021 14、市场营销观念：目标市场，顾客需求，协调市场营销，通过满足消费者需求来创造利润。18 七月 20212:11:31 下午14:11:31七月-21 15、我就像一个厨师，喜欢品尝食物。如果不好吃，我就不要它。七月 212:11 下午七月-2114:11July 18, 2021 16、我总是站在顾客的角度看待即将推出的产品或服务，因为我就是顾客。2021/7/18 14:11:3114:11:3118 July 2021 17、利人为利已的根基，市场营销上老是为自己着想，而不顾及到他人，他人也不会顾及你。2:11:31 下午2:11 下午14:11:31七月-21 ;;First three steps to CGMP compliance;Boundaries of Validation;Validation Life Cycle Approach;Validation Life Cycle Approach;Benefits of Validation;Elements Of Contemporary Validation In The US;cGMP and ISO-9000 - Similarities;cGMP and ISO-9000 - Differences;Benefits of the Systems Approach to Validation;The Validation Program;Part Two: GMP Requirements;GMP requirements;cGMP in the Pharmaceutical Industry;Regulatory Requirements for Validation.....;GMP Regulatory Requirements for Cleaning Validation;GMP Regulatory Requirements for Test Method Validation;GMP Regulatory Requirements for Test Method Validation;GMP Regulatory Requirements for Test Method Validation;PROCESS VALIDATION;Part Three: History and Expectations;History and expectations;Validation Targets;History of Validation;validation vs. VALIDATION;Elements of Contemporary Validation in the US;Expectations;Part Four: Validation;Who Validates?;Validation;Validation;Validation;Write Protocols;Example Data Sheets;Conduct Testing;Installation Qualification (IQ);Operational Qualification (OQ);Process Qualification (PQ);Definition of Process Validation;Definition of Process Validation;Stages of the Life-Cycl