Regulatory Compliance
Research Library
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MSDS Writer
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As OSHA's Hazard Communication Standard (HCS) nears its 25th anniversary since being adapted, the agency is considering modifications to the standard by incorporating elements of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). This system was initially adapted by the United Nations in 2002 with the goal of having as many countries as possible implement it by ...
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DZS Software Solutions
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The challenges facing our industry to effectively meet the clinical data study standards set out by the Clinical Data Interchange Standards Consortium (CDISC) specifically with regards to the Study Data Tabulation Module (SDTM) and the Analysis Data Model (ADaM) can be daunting. Our ADaM Data Conversion and Reporting Toolkit may be the solution you are looking for to generate all of your safety ...
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TUV SUD America Inc.
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On March 21, 2010, the EC Directive 2007/47/EC will become effective. This Directive will have a big impact on the Directives 90/385/EEC and 93/42/EEC. All manufacturers declaring conformity of their products to either of these EC Directives should be aware of the following: Medical devices according to 90/385/EEC or 93/42/EEC must also comply with the new EC Directive starting March 21, 2010 , ...
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DEACOM
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Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory ...
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Rondaxe
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How to Guide for Writing a Drug Master File Introduction A drug master file (DMF) is a proprietary document typically written by or for the manufacturer to protect manufacturing information, an intermediate, starting raw material, Active Pharmaceutical Ingredient (API), description of production site/s or for other special requests. Most often, DMF's are written to protect the manufacturing ...
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