Risk-Based Cleaning Validation, Maximum Safe Carry Over, & Process Automation

Learning Level: Intermediate
Time: 1100 - 1200 ET
Session Length: 1 hour

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.

Learning Objectives

  1. Understand how a risk-based approach can be applied to the cleaning validation program. 
  2. Learn how to use science-based strategy for managing your marker compounds and potent products.
  3. Insight into the approach to calculate and select the Maximum Safe Carry (MSC) for validation and monitoring samples.
  4. Recognize the advantages of automation to achieve data integrity, and regulatory compliance, for cleaning validation data.



Susan Cleary
Director of Product Development
Novatek International
Igor Gorsky, BS
Principal Consultant
ValSource LLC

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