Webinar

Digital Cleaning Validation Lifecycle

The industry has moved toward a structured, risk-based lifecycle approach following FDA's Process Validation Lifecycle guidance. See how to automate and digitize your cleaning validation with purpose-built tools.

Cleaning validation is a complex process. Using manual, paper- or Excel-based processes creates a challenge to eliminate error.

Over the years, the industry has moved toward a structured, risk-based lifecycle approach following FDA's Process Validation Lifecycle principal guidance. Purpose-built software significantly aids in this transition.

This presentation shows how to automate and digitize your cleaning validation program to help users consistently perform their activities within an efficient, safe, and compliant cleaning validation program.

Topics covered in this session:

  • Pain points of paper-based cleaning validation
  • Cleaning validation lifecycle model following ICH9 risk management principles
  • Automated product and equipment assessments
  • Automated worst case product and equipment identification
  • Residual limit calculations with integrated analytical method limits
  • Critical cleaning matrices development
  • Managing the cleaning validation program
  • Cleaning validation documentation

Takeaways:

  1. How to digitize the end-to-end cleaning validation life cycle
  2. Project management and task dependency
  3. Utilizing the power of data for the dashboard and quality metrics

Presented by:

Rui Almeida

Director - Consulting Services

ValGenesis

Profile

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