This document discusses regulations for nutraceuticals in India and the United States. It provides an overview of the key regulatory bodies - the FSSAI in India and DSHEA in the US. Requirements for product registration are outlined for both countries, including necessary documentation like application forms, labeling details, and evidence of safety. While regulations differ between the two locations, the goal in each is to ensure nutraceutical products are safely manufactured and their claims are truthful.
The document discusses regulations for cosmetics in the European Union. It covers several key points:
1) The EU has strict regulations to ensure consumer safety while promoting innovation in the cosmetics sector. Products must be notified to authorities and comply with all relevant laws.
2) Importing cosmetics to the EU is complex, requiring compliance with regulations. Products must not be dangerous or potentially harmful.
3) Manufacturers must maintain an up-to-date Product Information File with product details and make it available for review. Non-compliance can result in market withdrawal or legal penalties.
What is an RDA Europe Node and how to get involved. Webinar by RDA Europe 4.0 to introduce the network of RDA Europe nodes and the process to become a new node.
This standard provides requirements for testing dietary supplements to ensure ingredients are accurately identified and labeled. It requires supplements to be tested to confirm identity, quantity, and limits on contaminants like metals, pesticides, and microbes. The standard also provides criteria for good manufacturing practices. It applies to supplements containing vitamins, minerals, herbs, amino acids, or other botanical ingredients but excludes conventional foods.
The document discusses the Therapeutic Goods Administration (TGA) which regulates therapeutic goods in Australia. The TGA was established in 1990 to regulate medicines, medical devices, biologicals and other therapeutic goods. It evaluates products pre-market and monitors them post-market to ensure they meet standards of quality, safety and efficacy. The TGA uses a risk-based approach to regulation, with higher risk products facing more regulatory controls like prescription-only status. It works to align Australian regulations with international guidelines from places like the EU and US.
Sistemas Multimídia - Aula 04 - O Que é Multimídia (Ambientes Multimídia e Pr...Leinylson Fontinele
O documento discute os ambientes e produtos multimídia. Apresenta a evolução da digitalização da tecnologia e informação, desde ambientes não-interativos até ambientes gráficos. Detalha ambientes textuais e gráficos e como a animação e som foram incorporados. Produtos multimídia são classificados como títulos lineares, hipermídia e aplicativos com interface ou processamento multimídia.
This document discusses regulations for nutraceuticals in India and the United States. It provides an overview of the key regulatory bodies - the FSSAI in India and DSHEA in the US. Requirements for product registration are outlined for both countries, including necessary documentation like application forms, labeling details, and evidence of safety. While regulations differ between the two locations, the goal in each is to ensure nutraceutical products are safely manufactured and their claims are truthful.
The document discusses regulations for cosmetics in the European Union. It covers several key points:
1) The EU has strict regulations to ensure consumer safety while promoting innovation in the cosmetics sector. Products must be notified to authorities and comply with all relevant laws.
2) Importing cosmetics to the EU is complex, requiring compliance with regulations. Products must not be dangerous or potentially harmful.
3) Manufacturers must maintain an up-to-date Product Information File with product details and make it available for review. Non-compliance can result in market withdrawal or legal penalties.
What is an RDA Europe Node and how to get involved. Webinar by RDA Europe 4.0 to introduce the network of RDA Europe nodes and the process to become a new node.
This standard provides requirements for testing dietary supplements to ensure ingredients are accurately identified and labeled. It requires supplements to be tested to confirm identity, quantity, and limits on contaminants like metals, pesticides, and microbes. The standard also provides criteria for good manufacturing practices. It applies to supplements containing vitamins, minerals, herbs, amino acids, or other botanical ingredients but excludes conventional foods.
The document discusses the Therapeutic Goods Administration (TGA) which regulates therapeutic goods in Australia. The TGA was established in 1990 to regulate medicines, medical devices, biologicals and other therapeutic goods. It evaluates products pre-market and monitors them post-market to ensure they meet standards of quality, safety and efficacy. The TGA uses a risk-based approach to regulation, with higher risk products facing more regulatory controls like prescription-only status. It works to align Australian regulations with international guidelines from places like the EU and US.
Sistemas Multimídia - Aula 04 - O Que é Multimídia (Ambientes Multimídia e Pr...Leinylson Fontinele
O documento discute os ambientes e produtos multimídia. Apresenta a evolução da digitalização da tecnologia e informação, desde ambientes não-interativos até ambientes gráficos. Detalha ambientes textuais e gráficos e como a animação e som foram incorporados. Produtos multimídia são classificados como títulos lineares, hipermídia e aplicativos com interface ou processamento multimídia.
Interação Humano Computador Capítulo 11 - Análise de AtividadesWellington Oliveira
Este documento discute a análise de tarefas na interação humano-computador. Apresenta a diferença entre metas, tarefas e ações e descreve técnicas como análise hierárquica de tarefas e modelo cognitivo GOMS. O objetivo é entender os processos cognitivos envolvidos na realização de tarefas utilizando tecnologias dentro de um determinado domínio.
PUC - Rio | Pontifícia Universidade Católica do Rio de Janeiro
Pós-graduação em Ergodesign de Interfaces: Usabilidade e Arquitetura de Informação
Professor: Edson Rufino
Aluna: Fernanda Sarmento
Avaliação Heurística
A avaliação heurística (Nielsen e Molich, 1990; Nielsen 1994) é um método para encontrar possíveis problemas de usabilidade em uma interface que consiste em recrutar um conjunto de avaliadores que examinarão a interface e avaliarão a sua conformidade com princípios de usabilidade já reconhecidos (chamados de "heurística").
Vantagens do uso do método: Feedback rápido e barato quando comparado a um teste de usabilidade; é possível executá-lo bem no início do processo de design, pode ser usado em conjunto com outras técnicas.
Desvantagens: Demanda conhecimento/experiência para aplicar as heurísticas de forma eficaz, portanto, pode ser difícil encontrar profissionais qualificados, a avaliação pode acabar identificando apenas problemas “menores”.
Redigido a partir de:
https://www.nngroup.com/articles/how-to-conduct-a-heuristic-evaluation/ + http://www.usability.gov/how-to-and-tools/methods/heuristic-evaluation.html
Este documento discute técnicas de design de interação e usabilidade, incluindo:
1) Personas são usadas para representar usuários fictícios de um produto;
2) Avaliações de usabilidade podem ocorrer em diferentes momentos do ciclo de vida de um produto e podem ser empíricas ou analíticas;
3) A avaliação heurística é um método analítico popular que avalia um produto com base em um conjunto de heurísticas de usabilidade.
Food Safety Modernization Act (FSMA), a system in which the food industry systematically puts in place measures proven effective in preventing contaminations. http://www.foodsafetyspecialists.com/consulting.htm
Japan drug and cosmetics regulation.pdfBhavikaAPatel
The Pharmaceuticals and Medical Devices Agency (PMDA) is the main regulatory body for pharmaceuticals and medical devices in Japan. It was established in 2004 to review drugs and medical devices, monitor post-marketing safety, and provide regulatory services. PMDA conducts reviews of clinical trial applications, new drug applications, and medical device applications to evaluate safety, efficacy, and quality. It aims to protect public health while facilitating efficient development of drugs and devices. PMDA's reviews and consultations are a major part of bringing new pharmaceuticals and medical technologies to the Japanese population.
This document provides an overview of the U.S. Food and Drug Administration's Food Safety Modernization Act and its future impact on food importers and manufacturers in Asia. It discusses key components of the act related to prevention, inspections and compliance, import safety, and enhanced partnerships. The act aims to shift the U.S. food safety focus from response to prevention. It establishes standards for food production and imports and increases inspections of domestic and foreign facilities. Foreign manufacturers will face greater oversight and responsibility to meet new food safety requirements.
IBM Detailed ALM/ELM for Aerospace & Defence overviewImran Hashmi
Check out more info at https://hashmi.ca
IBM Detailed ALM/ELM for Aerospace & Defence overview
Challenges & Trends in Aerospace/Defense industry
IBM Engineering platform for Aerospace/Defense
The A&D demonstrator
Engineering Lifecycle Management Solution for A&D capabilities
Deeper Dive: Accelerating Industry Compliance for Aerospace:
ARP4754 and DO178C
Summary and additional resources
https://hashmi.ca
This Circular provides guidance on contents and presentation of nutrients and their values (hereinafter referred to as "nutrition facts") on food labels, and the roadmap for implementation with regard to prepackaged foods that are manufactured, sold, imported into, circulated in Vietnam.
The document discusses good manufacturing practices (GMP) for neutraceuticals. It outlines the general requirements for premises where neutraceuticals are manufactured, including ensuring premises are designed for easy cleaning and maintenance. Facilities must be provided for ventilation, lighting, water supply and drainage. Equipment must be designed to prevent contamination and ensure products are consistently produced according to quality standards. Personnel hygiene facilities like hand wash basins must also be provided and kept clean. The document provides details on cleaning procedures, waste disposal, pest control, and water supply requirements to ensure neutraceuticals are manufactured under hygienic conditions.
This document discusses various types of aggregate safety reports that are submitted to regulatory agencies, including Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), Development Safety Update Reports (DSUR), and Periodic Safety Update Reports (PSUR). It provides details on the purpose, format, and submission requirements for PSURs to agencies in countries like India, Europe, Singapore, Canada, Japan, and Australia. The significance of each report is also summarized.
Interação Humano Computador Capítulo 11 - Análise de AtividadesWellington Oliveira
Este documento discute a análise de tarefas na interação humano-computador. Apresenta a diferença entre metas, tarefas e ações e descreve técnicas como análise hierárquica de tarefas e modelo cognitivo GOMS. O objetivo é entender os processos cognitivos envolvidos na realização de tarefas utilizando tecnologias dentro de um determinado domínio.
PUC - Rio | Pontifícia Universidade Católica do Rio de Janeiro
Pós-graduação em Ergodesign de Interfaces: Usabilidade e Arquitetura de Informação
Professor: Edson Rufino
Aluna: Fernanda Sarmento
Avaliação Heurística
A avaliação heurística (Nielsen e Molich, 1990; Nielsen 1994) é um método para encontrar possíveis problemas de usabilidade em uma interface que consiste em recrutar um conjunto de avaliadores que examinarão a interface e avaliarão a sua conformidade com princípios de usabilidade já reconhecidos (chamados de "heurística").
Vantagens do uso do método: Feedback rápido e barato quando comparado a um teste de usabilidade; é possível executá-lo bem no início do processo de design, pode ser usado em conjunto com outras técnicas.
Desvantagens: Demanda conhecimento/experiência para aplicar as heurísticas de forma eficaz, portanto, pode ser difícil encontrar profissionais qualificados, a avaliação pode acabar identificando apenas problemas “menores”.
Redigido a partir de:
https://www.nngroup.com/articles/how-to-conduct-a-heuristic-evaluation/ + http://www.usability.gov/how-to-and-tools/methods/heuristic-evaluation.html
Este documento discute técnicas de design de interação e usabilidade, incluindo:
1) Personas são usadas para representar usuários fictícios de um produto;
2) Avaliações de usabilidade podem ocorrer em diferentes momentos do ciclo de vida de um produto e podem ser empíricas ou analíticas;
3) A avaliação heurística é um método analítico popular que avalia um produto com base em um conjunto de heurísticas de usabilidade.
Food Safety Modernization Act (FSMA), a system in which the food industry systematically puts in place measures proven effective in preventing contaminations. http://www.foodsafetyspecialists.com/consulting.htm
Japan drug and cosmetics regulation.pdfBhavikaAPatel
The Pharmaceuticals and Medical Devices Agency (PMDA) is the main regulatory body for pharmaceuticals and medical devices in Japan. It was established in 2004 to review drugs and medical devices, monitor post-marketing safety, and provide regulatory services. PMDA conducts reviews of clinical trial applications, new drug applications, and medical device applications to evaluate safety, efficacy, and quality. It aims to protect public health while facilitating efficient development of drugs and devices. PMDA's reviews and consultations are a major part of bringing new pharmaceuticals and medical technologies to the Japanese population.
This document provides an overview of the U.S. Food and Drug Administration's Food Safety Modernization Act and its future impact on food importers and manufacturers in Asia. It discusses key components of the act related to prevention, inspections and compliance, import safety, and enhanced partnerships. The act aims to shift the U.S. food safety focus from response to prevention. It establishes standards for food production and imports and increases inspections of domestic and foreign facilities. Foreign manufacturers will face greater oversight and responsibility to meet new food safety requirements.
IBM Detailed ALM/ELM for Aerospace & Defence overviewImran Hashmi
Check out more info at https://hashmi.ca
IBM Detailed ALM/ELM for Aerospace & Defence overview
Challenges & Trends in Aerospace/Defense industry
IBM Engineering platform for Aerospace/Defense
The A&D demonstrator
Engineering Lifecycle Management Solution for A&D capabilities
Deeper Dive: Accelerating Industry Compliance for Aerospace:
ARP4754 and DO178C
Summary and additional resources
https://hashmi.ca
This Circular provides guidance on contents and presentation of nutrients and their values (hereinafter referred to as "nutrition facts") on food labels, and the roadmap for implementation with regard to prepackaged foods that are manufactured, sold, imported into, circulated in Vietnam.
The document discusses good manufacturing practices (GMP) for neutraceuticals. It outlines the general requirements for premises where neutraceuticals are manufactured, including ensuring premises are designed for easy cleaning and maintenance. Facilities must be provided for ventilation, lighting, water supply and drainage. Equipment must be designed to prevent contamination and ensure products are consistently produced according to quality standards. Personnel hygiene facilities like hand wash basins must also be provided and kept clean. The document provides details on cleaning procedures, waste disposal, pest control, and water supply requirements to ensure neutraceuticals are manufactured under hygienic conditions.
This document discusses various types of aggregate safety reports that are submitted to regulatory agencies, including Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), Development Safety Update Reports (DSUR), and Periodic Safety Update Reports (PSUR). It provides details on the purpose, format, and submission requirements for PSURs to agencies in countries like India, Europe, Singapore, Canada, Japan, and Australia. The significance of each report is also summarized.
4. اولا : الانتقـــال مفهوم الانتقال : هو انتقال نقطة او شكل كامل من مكانه الي مكان اخر في المستوي بمعرفة 1 - اتجاه الانتقال 2 – مسافة الانتقال ملاحظة هامة الصورة = الانتقـــال + النقطــة الانتقـــال = الصورة - النقطــة النقطـــة = الصورة – الانتقـــال
5. 3 سم في الشكل المرسوم امامك النقطة أ م ن حيث م ن = 3 سم المطلوب ازاحة النقطة أ في اتجاه م ن مسافة قدرها 3 سم خطوات العمل : 1 – من أ نرسم شعاعا يوازي م ن وفي نفس الاتجاه 2 – علي هزا الشعاع عين النقطة أ بحيث ان أ أ = 3 سم تسمي النقطة أ صورة النقطة أ بالانتقال مسافة م ن في اتجاه م ن م ن 3 سم أ أ
6. انتقال شكل هندسي : أ ب ج أ ب ج م ن في الشكل المقابل تم نقل المثلث أ ب ج في اتجاه م ن مسافة قدرها = م ن فاصبحت صورة المثلث هي أ ب ج وتم العمل بنقل نقطة نقطة من الشكل بنفس الطريقة السابقة
7.
8. ثانيا : الـــدوران مفهوم الدوران : هو تعيين صورة نقطة او شكل هندسي بالدوران حول نقطة بزاوية قياسها معلوم و أ أ 60 ارسم صورة النقطة أ بالدوران حول نقطة و بزاوية قياسها 60 ؟ نرسم و ا ونضع صفر المنقلة عند النقطة و ونعين الشعاع بزاوية 60 نركز بالفرجار عند النقطة و وبفتحة تساوي و أ نعين أ علي الشعاع النهائي للزاوية 60 تسمي النقطة أ انها صورة النقطة أ بالدوران حول النقطة و بزاوية قياسها 60
9. الدوران في المستوي الاحداثي : الدوران حول نقطة الاصل و (0 , 0 ) 1- الدوران بزاوية قياسها 90 حول نقطة الاصل للنقطة ( س , ص ) يكون هو النقطة ( - ص , س ) 2- الدوران بزاوية قياسها 180 حول نقطة الاصل للنقطة ( س , ص ) يكون هو النقطة ( - س , - ص )
10. مثال هام : ارسم صورة المثلث ( و أ ب ) بالدوران حول نقطة الاصل بزاوية قياسها 90 و أ ب (1 , 3 ) ( 2 , 0 ) الحــل صورة النقطة أ ( 1 , 3 ) بالدوران حول نقطة الاصل بزاوية قياسها 90 هي أ ( -3 , 1 ) صورة النقطة ب ( 2 , 0 ) بالدوران حول نقطة الاصل بزاوية 90 هي ب ( 0 , 2 ) أ (-3 , 1 ) ( 0 , 2 ) ب
