Keyboard Illustration Webinar

Webinar: Process Validation Within the Quality System

Mesa Labs recently hosted a Webinar on Process Validation within the Quality System. We are now happy to provide the recording of the entire 45-minute informational presentation, led by our DataTrace Product Manager, Bradley Pickard, to answer the following questions: Do I have confidence in my manufacturing process, or what scientific evidence assures me that my process…

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FDA Code of Federal Regulations Title 21, Section 820.75

Section 820.75 of the FDA Code of Federal Regulations Title 21 defines the Process Validation requirements of 21CFR820.70 – Production and Process Controls. The Process Validation requirements include: Validation of the production process is required if the final results of a process cannot be verified by subsequent inspection or testing. The validation testing and results,…

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New FDA Food Safety Modernization Act (FSMA) Rules Published

The U.S. Food and Drug Administration (FDA) has made two final Food Safety Modernization Act (FSMA) rules public: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals JDSupra Business Advisor published an article discussing an overview of…

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Differentiating Design Validation & Design Verification

Design Validation frequently gets confused with Design Verification – they are quite different processes, though.  With verification, you’re making sure that the product meets the requirements identified by customers and regulations.  Validation is where you actually build a functioning version of the product to make sure it performs as expected. In Section 820.3(z), the FDA…

Dr. Sandle

Dr. Sandle on Cleanrooms & Contamination

For pharmaceutical manufacturers, hospitals and other facilities that contain cleanroom technology, the risk of contamination can be avoided by implementing proper environmental controls. These controls range from efficient cleanroom design to implementing gowning procedures. A full, detailed article on what you can do at your facility to maintain workplace safety and prevent contamination is available…