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Pharmaceuticals Research Library

FDA Inspection – A Survival Guide
Tutela Monitoring Systems LLC
While the FDA are the regulatory body, there is actually no legal requirement to respond to a Form 483 inspection report. According to the FDA’s own website, a form 483 report records “inspectional observations, and do not represent a final agency determination regarding your compliance.” It all sounds quite benign, but the consequences and ramifications can be serious and a timely, proper, ...
 
Cold Chain Qualification eBook
Fisher BioServices
“Cold Chain” refers to the undisrupted series of logistical activities (packaging, shipping, storage, distribution, handling) for products that must be maintained within a given temperature range. And as those of us in the biopharmaceutical industry know well, maintaining cold chain is critical to the integrity of biologically derived therapeutic products. The Centers for Disease Control and ...
 
Implementation of LEAN Techniques in Baxter's QC Laboratory
Baxter's BioPharma Solutions business
Implementing LEAN Techniques in Quality Control Optimizing and Leveraging Improved Efficiency Implementation of LEAN Techniques in Baxter’s QC Laboratory Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Baxter’s contract manufacturing facility in Halle/Westfalen, Germany, has been applying LEAN techniques since ...
 
United States Biological ELISA General Protocol
United States Biological
The protocols described in this paper are for general application. Any product specific protocol supercedes these general recommendations: •Direct ELISA is suitable for the detection of protein-based antigens can be performed when the desired antibody is available in a conjugated form. •Indirect ELISA is required if the primary antibody is not conjugated. With Indirect ELISA, a conjugated ...
 
Drug Sample Acceptance Preferences in U.S. Medical Offices
SK&A, A Cegedim Company
Drug Sample Acceptance Preferences in Medical Offices Physician Specialty, Ranked by Drug Sample Acceptance at Site Drug Sample Acceptance Preferences, Alphabetically by Physician Specialty Drug Sample Acceptance, Ranked by Specialists Who Prefer Sales Rep Visits Drug Sample Acceptance Preferences, by Site Size
 
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The Jackson Laboratory Company

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Tutela Wireless Temperature Monitoring Tutela Monitoring Systems LLC Tutela wireless temperature monitoring systems are fully FDA compliant, deliver unparalleled accuracy, and rock-solid audit trails for complete regulatory ...
 
Jackson Laboratory's legacy of genetic discovery The Jackson Laboratory The Jackson Laboratory has been a significant force in genetic discovery for more than 80 years. We discover the genetic basis for preventing, treating ...
 

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Fisher BioServices Company
Baxter's BioPharma Solutions business Pharmaceuticals
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