Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

2012 Memos

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December 2012  Grouping of Surfaces for Swab Recovery Studies?

November 2012 Selecting the Number of Validation Runs for Equipment Grouping

October 2012 Addendum Another Critique of Risk-MaPP

October 2012 Revisiting Limits Based on Process Capability

September 2012 My Revised Shorthand for Expressing Limits

August 2012 Differences between Cleaning and Process Validation

July 2012 Significance of Water Activity for Cleaning Validation

June 2012 Regulatory Guidances I'd Like to See Changed-Part 2

May 2012 Regulatory Guidances I'd Like to See Changed-Part 1

April 2012 How to Completely Avoid Doing Cleaning Validation          

March 2012 How Are ADE's Determined for Non-Highly Hazardous Actives?

February 2012 Hold Time Issues

January 2012 Issues in Cleaning Validation for Parts Washers