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  • FDA Inspection Guideline FDA Inspection Guideline

    This comprehensive 17 slide guideline provides practical "how to" advice for any organizations subject to FDA regulatory review. The guideline draws from more than 50 years of regulatory expert opinion...
    This comprehensive 17 slide guideline provides practical "how to" advice for any organizations subject to FDA regulatory review. The guideline draws from more than 50 years of regulatory expert opinion...
    $24.99
  • Checklist 01- FDA Inspection Preparation Checklist 01- FDA Inspection Preparation

    This checklist gives the user a description of critical preparatory steps to take in order to be ready for the next time the FDA comes knocking at the door.
    This checklist gives the user a description of critical preparatory steps to take in order to be ready for the next time the FDA comes knocking at the door.
    $0.00
  • Checklist 02 - Best practices for managing an FDA Inspection Checklist 02 - Best practices for managing an FDA Inspection

    This checklist describes how to conduct the FDA inspection. It provides details on how to delegate critical tasks and how to organize a team behind the scenes for optimal results....
    This checklist describes how to conduct the FDA inspection. It provides details on how to delegate critical tasks and how to organize a team behind the scenes for optimal results....
    $9.99
  • Checklist 03 - Documentation Preparation Checklist Checklist 03 - Documentation Preparation Checklist

    This checklist gives the user a comprehensive description of all documents to have already prepared when FDA shows up at the door.
    This checklist gives the user a comprehensive description of all documents to have already prepared when FDA shows up at the door.
    $9.99
  • Annual Report of FDA Observations FY 2018 Annual Report of FDA Observations FY 2018

    A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual...
    A comprehensive annual overview of the most frequently cited cGMP violations from actual FDA inspections. This 30-page report graphically depicts inspection observations by category and provides specific detail from actual...
    $299.00
  • Issue 1016 May 15, 2019 Issue 1016 May 15, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to data integrity.
    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to data integrity.
    $29.99
  • Issue 1017 June 1, 2019 Issue 1017 June 1, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to packaging and labeling.
    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to packaging and labeling.
    $29.99
  • Issue 1018 June 15, 2019 Issue 1018 June 15, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to sterile manufacturing.
    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to sterile manufacturing.
    $29.99
  • Issue 1019 July 1, 2019 Issue 1019 July 1, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to active pharmaceutical ingredient manufacturing.
    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to active pharmaceutical ingredient manufacturing.
    $29.99
  • Issue 1020 July 15, 2019 Issue 1020 July 15, 2019

    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to data integrity.
    Highlights actual 483 observations pertaining to manufacturing controls, laboratory controls and medical device manufacturers.  This issue features observations pertaining to data integrity.
    $29.99
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