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Medical Device Cleanliness Establishing and Justifying Limit Values for Residual Analysis

9/12/2013 10:00 AM

Overview: This webinar will provide valuable guidance to medical device manufacturers on how to establish and justify limit values for cleanliness. There are several techniques that may be used to set these limits, including comparison involving statistics and historical data. Justification techniques include biocompatibility and risk assessment. Regardless of what technique is used, regulatory agencies expect that limit values will be set for residual analysis.

Why should you attend: The FDA and other regulatory agency do not intend to set acceptance specifications or methods for determining whether a cleaning process in validated. They expect medical device manufacturers to establish and justify cleanliness specification for their devices. Although some documents are in the pipeline, there is no approved standard that provides guidance on how set and justify limit values for residual analysis.

Areas Covered in the Session:

Expectations of regulatory agencies on cleanliness specifications

How to Express Residue Limit Values

Statistical Comparison

Baseline Comparison


Risk-based Assessment

When and how to adjust limit values

Who Will Benefit:

QA/QC managers and personnel

Validation managers and personnel

Operations and Manufacturing

R&D and Engineering

R&D management

Engineering management

Production management

Production engineers

Kierstan Andrascik has worked in the medical device industry for more than 12 years. She founded QVET Consulting in 2009 to assist medical device manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

Event Link -

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