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Nov
9

Sustainable Compliance for Out of Specifications (OOS) Results

 
 Seminar/trade show (noCPF)

When:

  09 Nov through 10 Nov 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/qc-laboratory-qms-data-integrity-out-of-specifications-oos-capa-seminar-training-80413SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Education / Legal / Other - Education

Keywords:

Event description:

Quality Control (QC) Unit plays a critical role in assuring the identity, strength, quality, purity, and stability of drugs and biologics. QC Unit is responsible to approve or reject all procedures and specifications impacting quality, and all components, raw materials and the drug at all stages of manufacture, including intermediates, drug substance and drug product (21 CFR 211.22). Robust Laboratory Quality Management Systems (QMS) are essential to achieve and maintain sustainable regulatory compliance in a QC Unit. The course will start with an introduction to roles and responsibilities of QC Unit with an overview of Laboratory QMS, then focusing on key quality systems or issues, such as data of exceptions, including out of specifications (OOS), and Corrective and Preventive Actions (CAPA). Out of Specification (OOS) test results have been a major concern during manufacture of drugs for many decades. To avoid OOS in order to release the product, it has been found during audits... Read more

Posting date:

24 October 2021  |  154 views

Placement:

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