SureDerm applications
therapeutic good administration -回复
therapeutic good administration -回复什么是治疗产品管理（Therapeutic Goods Administration，简称TGA）？治疗产品管理是澳大利亚政府负责监管和管理医疗器械、药品和生物制品的机构。
该机构的主要职责是确保这些产品的安全性、质量和疗效。
作为一个独立的监管机构，TGA负责批准和注册新的治疗产品，监督产品的生产和供应链，以及监测市场上已有产品的安全性和合规性。
TGA的职责包括以下几个方面：1. 批准和注册：TGA负责对各类治疗产品进行审批和注册。
这些产品包括医疗器械、药品和生物制品。
在申请审批过程中，TGA会评估产品的质量、安全性和疗效，确保其符合澳大利亚标准和法规要求。
只有通过TGA 的审批和注册过程，这些产品才能在澳大利亚市场上销售和使用。
2. 监督生产和供应链：TGA负责监督治疗产品的生产和供应链。
他们确保所有生产商都符合质量管理体系，并遵守生产规范和标准。
此外，TGA 还负责监控和审查治疗产品供应链，确保产品在从制造商到患者的过程中的有效性和安全性。
3. 安全和合规监测：TGA负责监测市场上已有的治疗产品的安全性和合规性。
他们会定期对市场上的产品进行风险评估和安全监测，及时发现和解决可能存在的问题。
TGA还会进行市场取样和测试，确保市场上的产品符合澳大利亚的安全标准和法规要求。
治疗产品管理的政策和流程：治疗产品管理的政策和流程主要由以下几个方面组成：1. 治疗产品分类和注册：TGA根据产品的特性和用途，将治疗产品分为几个不同的类别。
每个类别都有不同的审批和注册要求。
根据产品分类，生产商需要提交详细的技术和临床文件，以证明产品的质量、安全性和疗效。
2. 审批和注册过程：对于新的治疗产品，生产商需要通过TGA的审批和注册过程，以获取销售和使用许可。
这个过程包括提交申请、技术评估、临床评估、质量管理审核和许可审定等环节。
TGA会根据提交的文件和评估结果，做出最终的决定。
OpenText SAP测试服务商品介绍说明书
FlyerSAP T esting ServicesMeet Y our SAP Quality Challenges with OpenT ext SAP T esting ServicesExecutive SummarySAP matters. Users expect it to be robust, per-form, and function reliably. So you must improve the platform to match those expectations. The ever-increasing pace of change requires faster testing while ensuring current performance and existing functionality is not impacted.OpenT ext Professional Services offer a range of testing services to help your organization meet your SAP application delivery chal-lenges. The multiple test automation frame-works within our SAP testing services help you deliver high-quality changes to your SAP platform. We power our testing services with industry-proven OpenT ext Application Delivery Management (ADM) tools such as:■Application Lifecycle Management (ALM) ■Business Process T esting (BPT)■UFT One (UFT)■LoadRunner■Service VirtualizationUsing these tools and our considerable ex-pertise, OpenT ext Professional Services can rapidly complement your current SAP testing capability, or accelerate your efforts to new heights.SAP T esting Service TypesBecause every SAP platform is customized, every customer has different testing requirements. Our SAP testing services can be adapted to match your SAP test requirements and engagement model. We provide:■Functional T est Automation for SAP:A projectbased, fixedscope service using OpenT ext ALM, BPT, UFT and Service Virtualization platforms for system, integration or end-to-endSAP functional testing. ■Performance T esting for SAP: Use ourLoadRunner toolset to identify the causeof performance issues in your SAPplatform using fixedscope, fixed costload and performance testing.■T est Automation Frameworks for SAP:Let us build an SAP T est Frameworksuited to your SAP platform, and deliverusage and maintenance coaching.■T esting-as-a-Service (TaaS) for SAP:Created for those needing a moreextensive, predictable, but elastic testingservice, this engagement model includesfixed price testing deliverables andscalable, mixed-shore delivery.Functional T est Automationfor SAP ServicesThe OpenText Functional Test AutomationService for SAP is an opportunity to engagewith OpenT extProfessional Services experts;to discover how functional test automation canbuild, test, and execute a library of components,scripts, and test cases for their SAP platform.Activities generally include:■Expert consultations: We work withyour test/QA leads and SAP subjectmatter experts to review test requirementsand current test cases to determinethe most effective test automationscenarios.■Collaborative test plan: This covers thedetail that will deliver the required testingscope.■Automation: Potentially, new manual andautomated test cases, and the automationof older test cases.■T est cases: Manual and automated,executed to an agreed number test plan.■Documented feedback: OpenT ext will logany defects, and provide test executionresults and a comprehensive report.■Multi-methodology approach: We useeither traditional, iterative or agile methods.■Asset retention: Customers keep allengagement assets, and we coach userson using this capabilityWe have proved our practices, methodologies,approaches, standards, and templates in thefield of SAP platform quality and testing overmany years, across hundreds of projects. Wehave delivered our customers an acceleratedcapability to execute their SAP testing and en-joy new value from investments in OpenT extALM, BPT, UFT One and SV software.Performance T esting for SAPOpenText Performance Testing Servicesfor SAP is based on our industry-leadingLoadRunner software and measures applica-tion performance to reduce the risk of poorSAP platform performance in production. Theservice uses the LoadRunner SAP protocol tocreate iterative, automated test scripts, basedon customerdefined business processes ortest cases, to execute performance tests andprovide a summary of the run results.These results help you determine whether yourSAP platform changes are ready for productionor need further configuration and optimization.OpenT ext Performance T esting Services forSAP deliver validation services remotely forinternal, or Internet-accessible SAP servicesThis service includes:■An individual SAP performance testingprogram, including analysis, requirementscapture, and test plan creation.FlyerSAP T esting ServicesAutomated Scripts Virtualized ServicesFigure 1. A OpenT ext Performance test framework for SAP example■Performance test script creation and scenarios using OpenT ext LoadRunner technology, including any web generated load, and SiteScope profiles.■T est scenario execution, arranged iteratively for different performance test types.■Reports and log defects based on test results, and consultation with customer stakeholders.T est Frameworks for SAPWe deliver a rapidly implemented platform and SAP testing assets to help fill any knowledge or capacity shortfall, and the expertise to utilize the implemented test framework. We include these deliverables and activities:■Automation framework solution design, based on our ALM, BPT, UFT, LR and SV software, and third party integrations.■Ready-deployed software and integration solution.■Any testing script import or adaptation into the automation framework or test case automation to an agreed scope.■Mentoring for your team—you will be ready to begin using the framework solution. T esting-as-a-Service for SAPCustomer requirements for apps testing vary,and each customer is different. T estingasaService (TaaS) uses a fixed price, termbasedconsumption approach reducing the total costof quality, while increasing it.What Is T aaS?It is an elastic testing delivery model thatenables customers to scale their testing, withpredictable costs, based on fixedpriced test-ing deliverables.TaaS supports traditional, agile or hybrid ap-proaches to delivery and can work alongsideoutsourced delivery. We offer TaaS across allphases of testing, and for specific capabilitiessuch as functional, performance, security andmobile testing.How Is T aaS Priced?OpenT ext uses testing units, a relative mea-surement framework. Purchase units in min-imum monthly packs by ‘testing type’; theseassigned to your testing catalog services, asagreed through a OpenT ext term agreement.Consume them according to demand for SAPfor your preferred term and scope (see Figure 2).SAP T est Governance & PlanningValidate the prereqs, validate environments, build test plans, validate test dataSAP T est Execution & Optimization AssistExecute tests, results analysis & report, provide recommendations276641604820 Figure 2. Catalog Services & T est Unit examples for SAP T aaSFigure 3. OpenT ext Professional Services approach to T esting-as-a-ServiceWhat Does T aaS Include?Each T aaS service includes access to certified, platform-independent and highly productive OpenText testing professionals, enterprise testing methods, practices, and accelerators.How Does T aaS Work?Our TaaS model operates with the following basic tenets:■Managed test supply to ensure consistent, customer-focused engagement.■T esting on demand from a catalog with predictable costs.■Customers are empowered to manage their testing budgets.■Scaled up or down as required.■Full transparency—labor, expenses and other costs included.Why Choose T aaS?T aaS suits customers wanting to focus on their business and leverage our quality and testing expertise. T aaS lowers the cost of testing, im-proves time to-market, and minimizes risk by delivering testing services through a flexible, outcome-based delivery model.Why Choose OpenT extas Y our T aaS Partner?■Strong focus on outcomes with accountability■SLAs on quality and other business outcomes ■We bear any staff training and ramp upcosts■Governance using Internal dashboardsand KPIs■Flexible service packages with specificscope and SLAs■Decades of experience and IPThe OpenT ext ProfessionalServices DifferenceOpenT ext provides unmatched capabilities witha comprehensive set of consulting and imple-mentation services and unique intellectualproperty that help you drive innovation throughstreamlined and efficient software delivery:■Proven OpenT ext software solutionimplementation expertise.■More than 20 years of experience helpinglarge, complex, global organizations realizevalue from their OpenT ext softwareinvestments.■Rich intellectual property and unparalleledreach into product engineering.■Education and support servicesto ensure adoption.Learn MoreFind more information about our ProfessionalServices’ capabilities:OpenT ext Professional ServicesConnect with Us。
Pulsafeeder Technology全球液体处理技术和创新的说明书
Pulsafeeder Technology Since 1936, Pulsafeeder has been the global leader in fluids handling technology and innovation in chemical dosing. Pulsafeeder has built a foundation of success with thousands of installations in fluid handling applications. Our extensive product breadth enables us to provide the convenience and efficiency of single-source solutions across various industries. With manufacturing and distribution facilities located around the globe, Pulsafeeder ensures the availability of its products and service world wide to meet customers’ fluid handling needs. Pulsafeeder’s manufacturing facilities are world-class. Continually investing in the latest production equipment and manufacturing techniques maximizes control of product quality, manufacturing efficiency and production cost for fast, effective response to customers needs. Pulsafeeder manufactures and supplies equipment, systems, and accessories that compliment each other and provide the assurance that each piece of equipment will operate at maximum efficiency.Omni Series Pumps The OMNI series is designed to be an economical, compact, rugged, simple, and reliable diaphragm metering pump. It features an industrial design to work in just about anyapplication. OMNI series pumps are a reliable alternative for the customer looking fora simple and compact diaphragm metering pump. These reliable metering pumps are designed to perform in the widest range of chemical dosing applications.ChemicalFood & BeveragePharmaceuticalPetroleum Pulp & Paper Paints & Dyes Petrochemical Product Specifications • Flows to 3600 l/h (951 gph) at 60 Hz• Pressures to 10.3 Bar (150 psi)• Accuracy +/- 2% of flow• Temperatures to 65°C (150°F)Viscosity up to 1000 Maximum 3 m (10ft) Maximum Suction Pressure 5 psi or .4 bar less than design pressure Materials of Construction • Head materials in PVDF, 316 SS, and PP • Ball Valves - Ceramic, and 316 SS • Diaphragm - PTFE faced Hypalon Typical Applications • Acids • Caustics • Polymers • Bleaches • pH Control • Solvents • Dyes/Inks • Catalysts • Cleaning agents • And many moreGeneral Industries Steel IndustryMetering PumpsOMNI Metering Pumps and Controls are the economical standard for a reliable chemical feed pump with virtually no maintenance. The OMNI offers the following user friendly benefits:•Metering AccuracyTo +/- 2% of flow•Turndown CapacityAdjustable up to 1000:1 with MPC controls on selected models•Oil FreeGreased for life no oil to buy or change•Compact and LightweightSaves space and easy handling •Controller ReadyAdd an MPC when automatic pump control is required•Simple DesignEasy to install and operate•Highly EfficientQuiet and cool, standard fan cooledmotor design•Liquid End MaterialsPVDF, PP, & 316 SS•Rugged ConstructionIntended for indoor or outdoor service ifprotected from precipitation & directsunlight.PVDF316 SS316 SS316 SS316 SS 316 SS(DC2-6, DC7 has oil bath)OMNI DC2-DC6 Dimensions All weights shown without motors. Motor weights vary by manufacturer. *Weight shown is without MPC and motor. Add 8.3 kg / 18.3 lbs. for MPC.090.8210298.85221032192002455.578.9137.9272.6507.20.03.04.05.16.210.375.7860160046.265.8175249435200114.9227.2422.710.36.25.150Hz224475.71021751281952493204356908601300160026003200J K0.180.250.180.250.180.250.180.250.180.2560HzJK 0.180.250.180.250.180.250.180.250.180.25FrameA2(in.) (cm)A1(in.) (cm)B1(in.) (cm)B2 Max (in.) (cm)C1(in.) (cm)C2(in.) (cm)C3(in.) (cm)D1(in.) (cm)D2(in.) (cm)Weight Simplex/Duplex lbs (kg)OMNI DC7 Dimensions90 IEC100 IEC56C NEMA143/145TC 12.55 (31.9)13.24 (33.63)13.18 (33.48)13.18 (33.48)18.54 (47.1)18.54 (47.1)18.54 (47.1)18.54 (47.1)9.76 (24.8)9.76 (24.8)9.76 (24.8)9.76 (24.8)15.75 (40.0)15.75 (40.0)15.75 (40.0)15.75 (40.0)8.27 (21.0)8.27 (21.0)8.27 (21.0)8.27 (21.0)9.06 (23.0)9.06 (23.0)9.06 (23.0)9.06 (23.0)18.96 (48.2)18.96 (48.2)18.96 (48.2)18.96 (48.2)8.93 (22.7)8.93 (22.7)8.93 (22.7)8.93 (22.7)26.26 (66.7)26.26 (66.7)26.26 (66.7)26.26 (66.7)96/125lbs (43.64/56.8)96/125lbs (43.64/56.8)96/125lbs (43.64/56.8)96/125lbs (43.64/56.8)Model Shown: DC7 Duplex, J or K /DC7 uses MPC Vector for the speed only controller. Connections are flange with 1 1/2 NPT.Metering Pump Controller (MPC) DC 2-6 Models OnlyFor high technology in a simple to understand package at an economical price, add an MPC to the Omni pump to take advantage of complete system integration between metering pump and process.The MPC features:• Automatically control and display flow with a4-20 mA input HANDHELD keypad, and manual stroke control• Controls Pulsafeeder metering pumps up to 1000:1 turn down ratio• The IP56 (NEMA 4X) Handheld user interface is attached to the pump with 1.5 meters (4.5 feet) of cable• Optionally, the Handheld can be mounted up to 300 meters (1000 feet) away from the pump• Handheld displays flow rate of the pump in LPH or GPH • Use digital inputs and outputs to monitor and control:• Supply tank level• Pump flow verification• Remote status indication of pump (on/off)• Pump alarm status•Pump auto/manual statusMetering PumpController MPCVector Drive DC7 onlyOmni® is a registered trademark of Pulsafeeder, Incorporated. Hypalon and Viton are registered trademarks of E.I. DuPont Company.OMS-08 REV 01Visit us on the web at。
Aetna Better Health of New York 2023会员手册说明书
相伴同行Aetna Better Health of New York 管理式长期护理 (MLTC) 计划会员手册目录实用信息 (4)会员服务部提供的帮助 (6)MLTC 计划参保资格 (6)New York 独立评估机构 — 初始评估流程 (7)Aetna Better Health of New York MLTC 计划承保的服务 (10)护理管理服务 (10)其他承保服务 (11)限制 (13)在服务区域之外获得护理 (13)紧急医疗服务 (13)过渡性护理程序 (13)Money Follows the Person (MFP)/Open Doors (14)我们的计划不承保的 Medicaid 服务 (14)药房 (14)Aetna Better Health of New York 或 Medicaid 不承保的服务 (15)服务授权、行动和行动上诉 (16)事先授权 (16)同步审核 (17)回顾性审核 (17)我们收到您的服务授权请求后会怎样？ (17)事先授权请求的期限 (18)同步审核请求的期限 (18)什么是行动？ (19)行动通知的时间安排 (19)如何对行动提出上诉？ (20)如何联系我的计划以提出上诉？ (20)对于某些行动，您可请求在上诉流程期间继续获得服务 (20)计划就我对行动提出的上诉做出决定需要多长时间？ (20)快速上诉流程 (21)如果计划拒绝我的上诉，该怎么办？ (21)州立公平听证会 (21)州立外部上诉 (23)投诉与投诉上诉 (23)什么是投诉？ (24)投诉流程 (24)如何对投诉决定提出上诉？ (24)参保者监察官 (25)从 Aetna Better Health of New York MLTC 计划退保 (25)自愿性退保 (25)转移 (25)非自愿性退保 (26)文化和语言能力 (27)会员权利与责任 (27)会员权利 (27)会员责任 (28)预立医疗指示 (29)根据请求提供的信息 (29)实用信息名称 电话、传真、电子邮箱 地址Aetna Better Health of New York 会员服务部电话：1-855-456-9126传真：1-855-863-6421网站：/NewYorkAetna Better Health101 Park Avenue15th FloorNew City, NY 10178听障服务部New York 转接专线7-1-1非紧急交通接送服务致电您的护理管理团队或 AetnaBetter Health of New York 会员服务部，电话：1-855-456-9126 紧急医疗服务9-1-1LIBERTY Dental Plan提供的牙科服务1-855-225-1727(TTY 877-855-8039)EyeQuest 提供的视力服务1-855-873-1282周一至周五，早上 8 点至晚上 8 点语言翻译服务致电 Aetna Better Health ofNew York 会员服务部1-855-456-9126申诉与上诉致电 Aetna Better Health ofNew York 会员服务部1-855-456-9126传真：1-855-264-3822Aetna Better Health of New York Grievance & Appeals Department PO Box 810405801 Postal Road Cleveland, OH 44181名称电话、传真、电子邮箱地址欺诈和滥用热线1-855-456-9126516-227-7474Nassau 县社会服务部 (Departmentof Social Services, DSS)Suffolk 县社会服务部 (DSS) 631-854-99351-877-422-8411New York 市人力资源管理局 (Human ResourceAdministration, HRA)NY 老龄局518-474-7012NYS 金融服务管理局1-800-400-8882 New York StateDepartment of FinancialServicesPO Box 7209Albany NY, 12224-02091-866-712-7197New York 州卫生部管理式长期护理局New York 州卫生部（投诉）1-888-401-6582New York MedicaidChoice (Maximus)欢迎加入 Aetna Better Health of New York 管理式长期护理 (Managed Long-TermCare, MLTC) 计划。
说明书循证审核
说明书循证审核1、原研国药品说明书原研国药品说明书需查看包括美国食品药品管理局、欧洲药品管理局和日本药品与医疗器械管理局等政府机构批准的药品说明书。
2、MICROMEDEX数据库MICROMEDEX数据库是由美国Thomson Healthcare(汤姆生卫生保健信息集团)制作的数据库。
目前世界上已有超过90个国家、9000多个医疗机构、药学院、医药大学、医药研究单位、药厂使用此数据库。
MICROMEDEX不同于一般文摘索引型或全文型数据库，是世界上最大、最权威的事实型临床医药知识数据库，其内容是由医药学专家针对全世界2000余种医药学期刊文献进行分类、收集、筛选后，按照临床应用的需求，编写为基于实证的综述文献，直接提供给专业人士使用。
MICROMEDEX数据库季度更新，提供的信息具有准确、时效性强等特点,已成为广大医疗界人士广泛使用信息资源的重要工具。
MICROMEDEX数据库包含了药品咨询数据库、疾病咨询数据库、毒物咨询数据库、另类暨传统医学咨询数据库和病患教育咨询数据库。
MICROMEDEX药品咨询数据库可用于查找国家药品监督管理局未批准的超说明书用法、证据来源、证据等级和有效等级，是超说明书用药评价体系的重要循证工具。
3、医学文献检索相关的循证医学文献，检索文献的证据级别从高到低依次为：系统评价、随机对照试验、非随机试验、专家意见和专家共识、个案报道。
检索范围应覆盖专业的数据库和指南网，包括EMBASE、PubMed、Cochrane协作网等大型的医学文献数据库，以及美国国家指南文库、加拿大医学会临床实践指南、英国国家卫生与临床优化研究所和苏格兰校际指南网、中国循证医学网等高质量的循证指南网，以及中国学术期刊全文数据库、中国生物医学文献数据库、万方数据知识服务平台等。
4、证据质量医学文献可能存在方法学上的缺陷，势必会影响循证医学结果的可靠性。
因此，需采用Jadad量表和AMSTAR量表对随机对照试验（RCT）和非Cochrane系统评价进行质量评价，以明确引用文献证据质量的高低。
法国消费法典pdf
法国消费法典法国的消费者保护法律体系相当全面，旨在保障消费者的利益并确保公平交易。
以下是一些主要的法律和规章：1.Code de la Consommation（消费法典）：这是法国消费者保护的基本法律，于2008年3月4日颁布，目的是简化和现代化以前的法律，更好地保护消费者的权益。
它包括了关于销售合同、价格标示、产品安全、远程销售、消费者信息以及广告等方面的规定。
2.Loi du1er juillet1993relativeàla protection des consommateurs（1993年7月1日关于保护消费者的法律）：这部法律是消费法典的前身之一，涉及产品的质量和安全、价格标示、消费者教育等方面。
3.Décret du13février2007relatifàla programmation publique（2007年2月13日关于公共广播的法令）：虽然这不是一个专门针对消费者保护的法令，但它确保了消费者能够接收到有关产品和服务的准确信息。
4.Règlement du15décembre2016modifiérelatif au programme général des produits et services（修改后的2016年12月15日关于产品和服务一般条款的规定）：这个规定涉及销售和服务合同的标准条款，包括退款政策、保修条件等。
5.Loi n°2016-1321du28octobre2016de modernisation de la France,notamment en matière de justice des marchés etde consommation（2016年10月28日的现代法国法律，特别是在市场和消费者司法方面）：这项法律旨在提高市场效率，加强竞争和消费者保护。
社保特殊处理流程
社保特殊处理流程1.申请社保特殊处理需要准备哪些资料？What documents are required for applying for special treatment of social security?2.需要提供居民身份证、户口簿、申请表格等相关证明材料。
You need to provide your resident ID card, household register, application form and other relevant documents.3.提交申请材料后，会经过多长时间才能获得特殊处理的结果？How long does it take to get the result of the special treatment after submitting the application materials?4.通常情况下，审核结果将在1个月内通知申请人。
In general, the audit result will be notified to the applicant within one month.5.如果申请被拒绝了，是否可以提出申诉？If the application is rejected, can an appeal be made?6.可以根据相关法律法规进行申诉，但需要提供相关的证据和材料支持。
An appeal can be made according to relevant laws and regulations, but relevant evidence and materials need to be provided.7.在申请特殊处理期间，社保待遇是否会受影响？Will the social security benefits be affected during the application for special treatment?8.在申请正在审核期间，社保待遇会暂时保持原状态，直到审核结果出来。
FEMA GRAS program 美国香精和提取物制造商协会的公认安全无毒项目
femagrasprogram课前回顾与预习task认识美国香精和提取物制造商协会美国香精和提取物制造商协会的公认安全无毒项目学习查找公认安全无毒清单part1theflavorandextractmanufacturersassociationoftheunitedstates认识美国香精和提取物制造商协会1part2femagrasprogram美国香精和提取物制造商协会的公认安全无毒项目part3learntocheckgrasnoticeinventory学习查找公认安全无毒清单2302part2femagrasprogram美国香精和提取物制造商协会的公认安全无毒项目content1fulltext全文阅读in1959fematookitsinitialactionstoestablishanovelprogramtoassessthesafetyandgrasstatusofflavoringredientsasdescribedinthe1958foodadditivesamendmentstothefederalfooddrugandcosmeticactthefederallawgoverningtheregulationofflavorsandotherfoodingredients