Combination Products Handbook
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Combination Products Handbook
A Practical Guide for Combination Products and Other Combined Use Systems
Neadle, Susan
Taylor & Francis Ltd
10/2024
592
Mole
9781032291635
Pré-lançamento - envio 15 a 20 dias após a sua edição
Descrição não disponível.
Chapter 1 Introduction
Chapter 2 What is a Combination Product?
Chapter 3 Regulatory Strategies
Chapter 4 cGMPs
Chapter 5 Integrated Development
Chapter 6 Risk Management
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Chapter 8 Lifecycle Management: Design Transfer through Post Market
Chapter 9
9A. Best Practices and Considerations for Combination Products Inspection Readiness
9B. US Combination Product Inspections
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Chapter 11 Analytical Testing Considerations
Chapter 12 Biological Products Considerations
Chapter 13 Connected Health
Chapter 14 Evolving Global Regulatory Landscape
Chapter 2 What is a Combination Product?
Chapter 3 Regulatory Strategies
Chapter 4 cGMPs
Chapter 5 Integrated Development
Chapter 6 Risk Management
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Chapter 8 Lifecycle Management: Design Transfer through Post Market
Chapter 9
9A. Best Practices and Considerations for Combination Products Inspection Readiness
9B. US Combination Product Inspections
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Chapter 11 Analytical Testing Considerations
Chapter 12 Biological Products Considerations
Chapter 13 Connected Health
Chapter 14 Evolving Global Regulatory Landscape
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Combination products regulatory strategies;Therapeutic and diagnostic products;Biodegradable Drug Delivery Systems;Transdermal pumps and patches;Biologics and biosimilars;Combination products lifecycle management;Combination Product;Drug Eluting Contact Lenses;Contract Manufacturing Organizations;Antibiotic Loaded Bone Cements;BPCI Act;Combination Product Manufacturer;Ich Q9;Post-market Surveillance Activities;Combination Product Development;Vice Versa;DDC;Medicinal Product;Medical Device;Drug Device Combination Products;FDA Guidance;CE Mark;PFS;NB;Drug Product;Device Constituent;IMDRF;Developing Combination Products;Medical Device Quality Management System;Increased Injection Time;Ich Guidance Document
Chapter 1 Introduction
Chapter 2 What is a Combination Product?
Chapter 3 Regulatory Strategies
Chapter 4 cGMPs
Chapter 5 Integrated Development
Chapter 6 Risk Management
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Chapter 8 Lifecycle Management: Design Transfer through Post Market
Chapter 9
9A. Best Practices and Considerations for Combination Products Inspection Readiness
9B. US Combination Product Inspections
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Chapter 11 Analytical Testing Considerations
Chapter 12 Biological Products Considerations
Chapter 13 Connected Health
Chapter 14 Evolving Global Regulatory Landscape
Chapter 2 What is a Combination Product?
Chapter 3 Regulatory Strategies
Chapter 4 cGMPs
Chapter 5 Integrated Development
Chapter 6 Risk Management
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Chapter 8 Lifecycle Management: Design Transfer through Post Market
Chapter 9
9A. Best Practices and Considerations for Combination Products Inspection Readiness
9B. US Combination Product Inspections
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Chapter 11 Analytical Testing Considerations
Chapter 12 Biological Products Considerations
Chapter 13 Connected Health
Chapter 14 Evolving Global Regulatory Landscape
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Combination products regulatory strategies;Therapeutic and diagnostic products;Biodegradable Drug Delivery Systems;Transdermal pumps and patches;Biologics and biosimilars;Combination products lifecycle management;Combination Product;Drug Eluting Contact Lenses;Contract Manufacturing Organizations;Antibiotic Loaded Bone Cements;BPCI Act;Combination Product Manufacturer;Ich Q9;Post-market Surveillance Activities;Combination Product Development;Vice Versa;DDC;Medicinal Product;Medical Device;Drug Device Combination Products;FDA Guidance;CE Mark;PFS;NB;Drug Product;Device Constituent;IMDRF;Developing Combination Products;Medical Device Quality Management System;Increased Injection Time;Ich Guidance Document
