Webinar: Using Health-Based Exposure Limits (HBELs) to Assess Risk

Date: 06 September 2017 Location: Online Event City: Online Event Country: Online Event Click here for webinar registration Live Webcast: 11am EDT| 8am PDT | 4pm BST | 5pm CEST

Health-based exposure limits (HBELs) were introduced in the European Union in 2015 with very strict deadlines, and followed the introduction of acceptable daily exposures (ADEs) defined in SIPE’s Risk-MaPP Baseline Guide in 2010. These limit guidelines were established identify exposure risk in facilities that manufacture multiple products.

It has since become apparent to the inspectors that manufacturers were slow to adopt the guide approach and many did not have the expertise within their organizations to deliver HBELs.

Additionally, due to difficulties and inconsistencies in the application of previously used approaches in setting cleaning validation limits to the variety of pharmaceutical dosage forms, there was lack in consistency and consequently a lack in a proper risk assessment associated with carry-over.

 

           

 

This webcast will review:

  

• What are health-based exposure limits and why is this method better than previous methods used in cleaning validation?

  

• What are connections between HBELs used in GMP manufacturing and occupational exposure limits (OEL) used in industrial hygiene?

  

• What are good practices in applying HBELs to small- and large-molecule pharmaceutical manufacturing operations?

 

Speaker:

Ester Lovsin Barle, PhD, MscTox, ERT 

 Click here for webinar register

 

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