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QUALITY BY DESIGN (QbD) IN API by DR ANTHONY MELVIN CRASTO
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      Drugs And AddictionMedical EducationRegulatory Affairs
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      Intellectual PropertyAntitrust (Law)Intellectual Property LawIntellectual Property Rights
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      Regulation And GovernanceEnergy PolicyOil and gasRegulatory Affairs
HIPAA laws related to fundraising became fully effective in 2013. What protocols should be in place to maximize philanthropic opportunities under HIPAA? What compliance measures need to be in place and assessed to properly use protected... more
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      FinancePharmacyTax LawCompliance
IAS 8 spells out the specific principles, bases, conventions, rules and practices that are applied in preparing and presenting financial statements. When there is no specific standard that applies to a transaction, other event or... more
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      FinancePharmacyHealth CareBiotechnology
The ultimate target in the pharmaceutical and medical device industries is to ensure patient safety within the entire product life cycle, from R&D to distribution. This presentation reviews the current focal points from MHRA GMP... more
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      PharmacovigilancePublic HealthMedicineHealthcare
Overview: The FDA's Design History Files, Device Master Records, Device History Record, and the EU's MDD TF/DD -- Documentation to meet their different purposes and device classifications. This webinar will examine the existing and... more
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      FinanceBiotechnologyComplianceOnline Training
The coral reefs' crisis is increasing, with the combined effects of natural and anthropogenic disturbances. It is predicted that coral reefs could extinct soon from the world. Bangladesh has only one coral Island named Saint Martin,... more
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      Institutional TheoryCoral Reef EcologyRegulatory Affairs
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      Regulatory AffairsPharmaceutical Regulatory AffairsRegulatory ScienceRegulation of Medical Device
Using objective measures of investor protections in 170 countries, I establish that the level of investor protection matters for cross-country differences in GDP growth: countries with stronger protections tend to grow faster than those... more
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      BusinessEntrepreneurshipIndustrial And Labor RelationsCollective Bargaining (Industrial And Labor Relations)
Overview: A workplace emergency is an unforeseen event or occurrence that may threaten your employees, customers, or the public; disrupts or shuts-down your operations; or causes physical or environmental damage. Some Examples of... more
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      FinanceBiomedical EngineeringEthics & Compliance ManagementHealth Care Management
Overview: This webinar is intended to help you get familiar with the FDA-compliant management of medical device cybersecurity for regulatory purposes. This webinar is further intended to increase our awareness that effective management... more
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      FinancePharmacyBiomedical EngineeringEthics & Compliance Management
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      Civil LawCommercial LawRegulatory AffairsBlockchains
Overview: This webinar is intended to help you get familiar with compliance audits by the US Food and Drug Administration and Notified Bodies in European Union (EU). This webinar is further intended to help you understand what you can... more
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      FinancePharmacyBiotechnologyCompliance
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      Regulatory ComplianceCorporate LawRegulation And GovernanceCorporate Governance
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      PharmacologyHealth SciencesPharmacyInformatics
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      Intellectual PropertyCompetition LawRegulatory AffairsPublic Interest Litigation
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      Critical TheoryAmerican HistoryCultural StudiesPolitical Sociology
Overview For many organizations, the procure-to-pay cycle offers extensive opportunity for increased operational efficiency. However, it also provides potentially numerous opportunities for fraudsters to exploit control deficiencies in... more
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      FinanceTax LawBiotechnologyHuman Resource Management
A partire dall'esito referendario del 2011 e con la successiva attribuzione dei poteri di regolazione e controllo all'AEEGSI, il sistema idrico in Italia ha intrapreso un percorso di profonda evoluzione. Evoluzione che non ha solo... more
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      Integrated Water Resources ManagementRegulatory Affairs
The Guia Regulatoria de Registro en Suramerica: Dietary Supplement, is an essential resource for any dietary supplements products company that wants to do business in the global marketplace. From Argentina to Venezuela, the Guide provides... more
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      Nutrition and DieteticsRegulatory AffairsDietary Supplements
ABSTRACT This is a very brief textbook that introduces a basic explanation about the relationship between Law and Economics. In Chile, the study of Economics for Law Schools began in the middle of 20th century using the denomination “... more
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      Economical Analysis of LawLaw and EconomicsRegulationRegulatory Affairs
Typical Elements Required to be Included in the Batch Production and the Device History Record in order to Accomplish a Quality and Cost Effective Review and Quality Management system based on current Regulatory Expectations in accordance... more
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      PharmacyBiotechnologyComplianceFood and Nutrition
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      Regulatory AffairsPharmaceutical formulation and development
Overview: Have you ever wondered about how FDA approaches CAPA (corrective and preventive actions) and complaint issues during inspections? What about how they manage those activities and what they are looking for? This webinar will... more
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      Health SciencesPharmacyBiotechnologyCompliance
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      Discourse AnalysisSoutheast Asian StudiesMarxismHuman Rights
Overview: Complex processes with unknown risks, incorrect quality problem definition, and ineffective follow up of issues impede Corrective and Preventive Action (CAPA) processes. Moreover, generation of numerous CAPAs with varying... more
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      FinancePharmacyBiomedical EngineeringCompliance
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      Intellectual PropertyPublic Policy - Social Welfare PolicyRegulatory AffairsSostenibilità
Analytical method validation is an important requirement to support the package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Back in 1987, the US Food... more
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      ChemistryAnalytical ChemistryScience EducationMeasurement and Evaluation
This article is exploratory in nature and it is multidisciplinary in its approach and follows on from the literature on regulation from Public Policy, Economic Analysis of Law and Law and explores the establishment of independent... more
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      Regulation And GovernanceEnergy LawLaw and EconomicsRegulation
Abstract: Can sport "moves" be protected, as such? The absence of any original or creative form of expression because of their rulebound nature, the uncertainty of the end result of a game or competition and the lack of a scripted plot... more
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      Intellectual PropertyBaseballLegal TheorySports Management
QUALITY BY DESIGN (QbD) FOR API by DR ANTHONY MELVIN CRASTO
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      Medicinal ChemistryDrugs And AddictionRegulatory AffairsQbD
Overview: For many companies, Accounts Receivable Financing is the largest or second largest asset on the balance sheet. Therefore, any weakness in the financial controls for A/R could have a serious impact on the company’s financial... more
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      FinancePharmacyBiomedical EngineeringEthics & Compliance Management
Setting up controls for the purchasing process and analyzing the risk to the financial statements can be a daunting task. Since a large company has to purchase many different items every day, there is a real potential for fraud.
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      FinanceHuman Resource ManagementComplianceHealth Care Management
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      EconomicsPublic ManagementPolitical ScienceWest European Politics
The analysis is focused on the national blockade of truckers which strongly affected Brazil between 21 and 31 May 2018, and its direct repercussions on the regulatory agency‘s behavior. To solve this crisis, significant part of the... more
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      Regulatory AffairsIndependent Regulatory AgenciesSeparation of Powers
This book explains the rapid evolution of the Blue Box municipal recycling program in Ontario between 1982 and 1994 and its social and environmental costs. The origins of the Blue Box municipal recycling program in Ontario can partly be... more
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      Environmental ScienceEnvironmental EconomicsEnvironmental EducationEnvironmental Law
The term " Halal Laws " in this paper relate to the laws of consumer protection in terms of halal product. Halal laws are crucial, since it regulates an industry that is worth an estimated of USD 2.3 trillion, annually. The Halal laws in... more
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      Halal foodInternational LawFood and NutritionRegulatory Affairs
Hybridity on the Ground in Peacebuilding and Development engages with the possibilities and pitfalls of the increasingly popular notion of hybridity. The hybridity concept has been embraced by scholars and practitioners in response to the... more
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      Gender StudiesAnthropologyInternational RelationsDevelopment Studies
Overview: A discussion of good leadership skills (Behaviors, Relationships, Attitudes, Values, Environment), and its application to accelerating value-creation through inflection points. Leadership is about inspiring and enabling others... more
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      FinancePharmacyBiomedical EngineeringCompliance
Regulation of the financial sector has always been a prime concern of states and the regulatory bodies which usually put in place. This work undertakes an overview of Malaŵi's financial sector and the dominance of banking. It discusses... more
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      RegulationBanking & Financial ServicesRegulatory AffairsFinancial Services
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      PharmacologyPharmacovigilanceClinical PharmacologyRegulatory Affairs
Annex 1 to the European Union Good Manufacturing Practice (GMP) guidelines is now under formal revision, with a concept paper issued during February 2015 and with a view to implement the new document during 2016. Annex 1 is a key part of... more
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      PharmacologyPharmacyTechnologyPharmaceutical Technology
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      IndonesiaEconomic integrationNanotechnologyRegulatory Affairs
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      LeadershipPharmaceutical TechnologyRegulatory AffairsCMC regulatory strategy
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      Regulatory AffairsPharmaceutical Regulatory AffairsRegulatory ScienceRegulation of Medical Device
The present CLEER Paper collects some of the contributions that were presented during the roundtable organised by the T.M.C. Asser Institute in September 2015, in cooperation with the Dutch Ministry of Foreign Affairs. The papers focus on... more
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      Environmental LawSustainable DevelopmentEU External Relations LawEuropean Union Law
The fact that foods can provide additional medicinal health benefits beyond basic energy requirements and nutritional needs for survival, has been proven through rigorous scientific researches over the years. Although Turkey is... more
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      MicrobiologyFood ScienceRegulatory ComplianceProbiotics