This webinar will provide valuable guidance to medical device manufacturers on how to establish and justify limit values for cleanliness. There are several techniques that may be used to set these limits, including comparison involving statistics and historical data. Justification techniques include biocompatibility and risk assessment. Regardless of what technique is used, regulatory agencies expect that limit values will be set for residual analysis.
The FDA and other regulatory agency do not intend to set acceptance specifications or methods for determining whether a cleaning process in validated. They expect medical device manufacturers to establish and justify cleanliness specification for their devices. Although some documents are in the pipeline, there is no approved standard that provides guidance on how to set and justify limit values for residual analysis.
Areas to be Covered:
Expectations of regulatory agencies on cleanliness specifications
How to Express Residue Limit Values
When and how to adjust limit values
Who will Benefit:
QA/QC managers and personnel
Validation managers and personnel
Operations and Manufacturing
R&D and Engineering