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Sep
28

21 CFR Part 11, Data Integrity, and Computer System Validation

 
 Seminar/trade show (noCPF)

When:

  28 Sep 2021 through 29 Sep 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/fda-21-cfr-part-11-data-inegrity-csv-seminar-training-80611SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Medicine & Health - Pharmaceutical / Medicinal

Keywords:


Event description:

Through a wide variety of regulations, standards, and guidance, the U.S. FDA and other global regulatory competent authorities are increasingly focused on software used for numerous regulated purposes. Such uses include the management and analysis of clinical studies, product development, manufacturing, and the automation of Quality System elements such as complaint management, CAPA, management review, risk management, and document control. Each system within this scope must have evidence it was validated for its intended use. With the dual purpose of ensuring regulated software contributes to product safety and efficacy and of improving organizational compliance, regulatory authorities face not only the ubiquitous incorporation of these systems but increasingly complex technical environments. From their point of view, companies using software for regulated purposes also see a rapidly evolving technical landscape and a maturing regulatory environment, with increased technical com... Read more

Posting date:

22 August 2021  |  157 views

Placement:

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