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™

 

The number of electronic records generated through the manufacture of regulated products continues to grow. The knowledge from this data is directly used in the manufacture of drugs, which is critical to the quality of products and the safety of patients.

 

Our archived webinar, “"The Importance of Data Integrity for Endotoxin Testing," available in our QC Insider™ Training, presents the principles of data integrity using a risk-based approach, and how QC professionals can actually show ‘proof’ of data integrity in their process.

 

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

 

Already a Subscriber to the QC Insider™ Toolbox?    Not a QC Insider™ Expert Yet? 
Click on Data Integrity Webinar Archive, input your user name and password on the login page. You will then be directed to the Webinars landing page to access the new 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 Archive Webinar.

 

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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White Paper: Low Endotoxin Recovery - Beyond the Controversy                                                                                        

 

Topics include:

  • The impact (and potential impact) of LER on pharmaceutical manufacturing
  • Current understanding of LER, including its causes and likely mechanisms
  • Approaches to tackling LER that enable QC professionals to identify occurences of LER and take steps to avoid it
  • Regulatory responses to LER and the latest guidance from the FDA                                                          

      

Login or register to access the new technical tip.            

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