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  • 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
  • List of FDA Inspected Facilities Q1-2019 List of FDA Inspected Facilities Q1-2019

    A summary of FDA Inspections that were conducted between January 1, 2019, and March 31, 2019. Report is in excel format and allows you to sort as you need.  The report...
    A summary of FDA Inspections that were conducted between January 1, 2019, and March 31, 2019. Report is in excel format and allows you to sort as you need.  The report...
    $199.00
  • Quarterly Special Issue QSI-19Q3 - Change Control Quarterly Special Issue QSI-19Q3 - Change Control

    This is a comprehensive report on observations pertaining to Change Control.  There are observationsThere are observations from manufacturing facilities, device facilities and API manufacturers.
    This is a comprehensive report on observations pertaining to Change Control.  There are observationsThere are observations from manufacturing facilities, device facilities and API manufacturers.
    $19.99
  • 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 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 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 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 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
  • 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
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