Expert Support At Your Fingertips for the Bacterial Endotoxins Test

Become a QC Insider™ Expert and Register Now.

 

 

 

QC Insider - Endotoxin Expertise at Your Fingertips™

 

Data Integrity: a fundamental component in the pharmaceutical industry. What is there to know?  It “refers to the completeness, consistency, and accuracy of data.”
FDA Draft Guidance to Industry, “Data Integrity and Compliance with cGMP Guidance for Industry.” (4/2016)  

 

Our new Data Integrity FAQs Tech Tip, added to our QC Insider™ Library, focuses on the requirements of data integrity, what they mean and how they relate to
in-process and endotoxin release testing.

 

Other topics covered: 

 

  • Is gel clot testing affected by data integrity?
  • Comparison of qualitative vs. quantitative systems
  • How WinKQCL™ Software can help ensure compliance for data integrity in endotoxin testing

 

Already a Subscriber to the QC Insider™ Toolbox?    Not a QC Insider™ Expert Yet? 
After clicking on Data Integrity FAQs Tech Tip, input your user name and password on the login page. You will then be directed to the Tech Tips page where you can access the latest tool.   Register and you will be directed to a Registration Page. After you have successfully registered, you will be able to navigate through the QC Insider™ Toolbox and access the Data Integrity FAQs Tech Tip.

 

Delivered to you from the QC experts who face many of the same regulated manufacturing challenges as you do, the QC Insider™ Toolbox is packed with comprehensive support tools that will help you perform the bacterial endotoxins test.

 

Become a QC Insider™ expert and Register Now.

 

 

 

Explore Our Resources

 

QC Insider™ Support: direct access to one-on-one guidance and detailed information about software support, recertification & testing services, reader install & maintenance and workflow optimization.

 

QC Insider™ Training: self-directed training resources that will help you build on your bacterial endotoxins test expertise.

 

QC Insider™ Library: technical resources that will help ensure your success with the bacterial endotoxins test. You will have access to a collection of package inserts, quick guides, technical tips and more.

 


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Webinar Archive: The Importance of Data Integrity for Endotoxin Testing                                                                                        

Learn about the principles of data integrity using a risk-based approach. 

  

Topics include:            
  • Criteria for data integrity and recent guidance issued from the FDA
  • Kinetic vs. subjective test methods
  • How WinKQCL™ Software helps satisfy the 21 CFR Part 11 compliance requirement

                                                                                

      

Login or register to view the webinar.            

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