Advances in Cleaning Validation with a Data Integrity Compliant System

Thursday, September 12, 2019

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TOC has long been identified as an efficient and effective way to monitor cleaning validation and verification processes.  Using novel techniques with complementary data can provide insight into the trends and data.  But such triangulation requires careful management of data to ensure that current Data Integrity guidance documents and regulations are met.  Thus, deploying technology is only half of the process and aligning that technology to today’s data management requirements is equally critical.  This talk will discuss how Data Integrity regulations affect you and how TOC & conductivity measurements can offer insight to your cleaning validation program.

This webinar will cover the following topics:

  • Analyzing FDA’s Guidance on Data Integrity (December 2018), how it affects compliance, and recent FDA 483 review 
  • Reviewing 21 CFR Part 11, how it complements Data Integrity, and why it is still misunderstood
  • Comparing Data Integrity principles to EP and other consortia
  • Advances in cleaning validation using TOC, inorganic carbon (IC), and conductivity as predictive trends

Who should attend: 

  • Professionals in Cleaning Validation, Cleaning Program Design, and Equipment Qualification
  • Professionals in Analytical Method Development, Quality Control, and Quality Assurance


Mike Auerbach
American Pharmaceutical Review
Michelle Neumeyer
Life Science Product Applications Specialist
View Biography