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Oct
28

Data Integrity: FDA, WHO and EMA's Requirements

 
 Seminar/trade show (noCPF)

When:

  28 Oct through 29 Oct 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/data-integrity-fda-who-ema-cgmp-seminar-training-80397SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Education / Legal / Other - Education

Keywords:

Event description:

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced. Often the initial "hint" of an off-shore problem occurs within FDA "circles" when one first observes an "Import Alert". These Import Alerts don't offer much information other than the country, the Company and the product. However, this becomes a tell-tale signal that a Warning Letter will most likely be issuing within three to four months. Data Integrity issues may represent very simplistic issues that any auditor may readily observe to those that are so complex that only someone very skilled in the art of auditing can readily find th... Read more

Posting date:

28 August 2021  |  136 views

Placement:

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