The webinar will discuss the "science-based" and "risk-based" approaches to cleaning validation, and the current regulatory viewpoint.
The calculation of the maximum safe carryover (MSC) will be presented and analyzed to provide understanding of the changes to the current calculations and source of the data used in the calculation. The presentation will explore how automation of calculations fits into a risk-based Cleaning Validation lifecycle.
A brief case study demonstrating how automation facilitates the use of equations for specific carry over scenarios by operating companies. This presentation will provide details on how to use the HBELs in the carry over equations, and how to select and apply the MSC for product groupings and individual hazardous (potent) products.