Quality and Invention
Quality and Invention published 10 applications on Google Play, 3 people rated these apps with an average rating of 0.90!
BLA BookletThe Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant...
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EU-GMP ChapterGood manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended
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GCP BookletAdherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. The Food and Drug Administration’s...
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GMP BookletSince 1962 Amendment, US Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211. The word "current" was later added to create CGMP to imply...
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PMA/510k BookletPremarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PMA is an application submitted for approval to market. PMA approval is to be based on a determination...
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EU-GMP Annex1Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contaminatio
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EU-GMP GuideGood manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). EU-GMP is to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended
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GLP BookletThe various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, FDA promulga
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Molar CalculatorMolar Calculator is a user-friendly, simple, versatile App for calculating molecular weight and more. It contains a molecular weight calculator preset with the precise weights of 90 elements, including commonly used metallic elements in chemistry, for...
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QSR BookletMedical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated medical devices are known as Quality System...
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