Avoid recurrent microbial contamination using trending of historical data

Avoid recurrent microbial contamination using trending of historical data

03/23/2017, 11:30 AM - 12:15 PM

Meeting Room 1


"Control of microbiological contamination" is still one of the top 10 observations by FDA and EMA auditors. The goal of the presentation is to explain why microbial contamination control is often inadequate based on years of performing audits and benchmarking of several pharmaceutical companies. The presentation is based on case studies on recurring microbial contamination due to ineffective investigation and trending of data gathered during routine monitoring. To identify the root causes and resolve recurring microbial contamination deviation not only investigation in the field is important but also using historical data is key. The presentation will share how adequate risk based monitoring plan and historical data can help to design an effective cleaning and disinfection plan.


  • Walid El Azab


    Technical Service Manager

    STERIS Life Science

    Walid El Azab is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. He currently provides technical support related...


  • Avoid recurrent 1.90 MB

    Avoid Recurrent microbial contamination using trending of historical data


Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. At the end of the presentation the attendees will be able to understand: - Why “control of microbiological contamination” is on the top 10 list of observations by FDA and EMA auditors. - Common mistakes leading to recurrent microbial contamination 2. - That effective contamination control procedure must be based on adequate risk based monitoring plan. 3. - That efficient trending analysis will confirm effectiveness of the contamination control procedure in place.


  1. Track
    Leveraging Quality Systems & Strategies in a Heavily Regulated Environment

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