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Tuesday, December 12, 2017
   
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Pharmaceutical

Quality management system Preparation and Training

  • ISO 9001:2008 Quality management systems
  • IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
  • OHSAS 18001:2007 International Occupational Health and Safety Management Standard.
  • ISO 14001:2004  Environmental Management Systems
  • ISO 27001:2005 Information Security Management Systems (ISMS).
  • BS 25999-2 2007 Business Continuity Management (BCM)
  • ISO 50001:2011 Energy Management

international regulations Preparation and training

  • ICH requirements
  • EMEA requirements
  • 21CFR210/211 USA pharmaceutical requirements
  • registration of products worldwide

Good Practices Preparation and training

  • GMP Good Manufacturing practice
  • GLP Good Laboratory Practice
  • GHP Good Hygiene Practice
  • GDP Good Distribution Practice
  • GSP Good Storage Practice
  • GCP Good clinical Practice

Validation and testing

  • Microbiology testing
  • Moist heat validation including microbiology testing
  • Clean room validation including microbiology testing
  • packaging validation
  • accelerated stability study
  • environmental monitoring testing
  • warehouse thermal mapping
  • layout creation of new factory

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