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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, ...
 
DISINFECTION QUALIFICATION TESTING— CONSIDERATIONS FOR THE ASEPTIC AND CLEANROOM MANUFACTURING ENVIRONMENT
ATS Labs
Disinfection qualifications are critical in assuring the microbial control of a manufacturing environment by qualifying the appropriate use and effectiveness of disinfection products and procedures. Obtaining the highest confidence that aseptic, cleanroom, and other critical manufacturing environments are properly cleaned, sanitized and disinfected is paramount in assuring the production of safe ...
 
QP Essentials eBook
Fisher BioServices
QP Essentials: Your EU Gateway to Clinical and Commercial Distribution of Cell-Based Therapeutics By Colin Grant, Quality and Regulatory Manager, Fisher BioServices Biobanking & Cell Therapy Clinical Trial Biorepository Solutions Kit Production Clinical Trial Biologic-API Qualification / Sample Management Management Validation Services Colin Grant is the Regulatory and Quality Manager for ...
 
Samplicity™ System Delivers High-Performance Multi-sample Filtration While Streamlining Preparation of Chromatography Samples
EMD Millipore Bioscience
The Samplicity™ filtration system has helped researchers streamline chromatographic sample preparation in order to match the speed and throughput requirements of their analytical separations such as high/ultrahigh performance liquid chromatography (HPLC /UHPLC). An easy-to-use alternative to syringe filters, the Samplicity™ system enables simultaneous vacuum filtration of up to eight samples. ...
 
NuAire | When to replace your Biological Safety Cabinet
NuAire Inc.
WHEN SHOULD WE REPLACE OUR BIOLOGICAL SAFETY CABINETS Use of modern day Biological Safety Cabinets (BSC’s) began in the early 1970’s with BSC’s that were manufactured to the NIH-03-112C Standard and subsequently the NSF Standard 49. BSC’s manufactured in the 70’s, 80’s and early 90’s have provided well over 15 years of service. BIOLOGICAL SAFETY CABINETS HAVE A 15 YEAR USEABLE LIFE Several ...
 
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Calbiochem® Inhibitors EMD Millipore Bioscience For decades, Calbiochem® has manufactured high quality inhibitors, biochemicals, antibodies, proteins, and kits that have been cited in thousands of ...
 
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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The Jackson Laboratory Pharmaceuticals
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