Lessons learned from microbial contamination in pharmaceutical manufacturing –Benefit of end user and supplier collaboration

Lessons learned from microbial contamination in pharmaceutical manufacturing –Benefit of end user and supplier collaboration

04/18/2018, 4:15 PM - 5:00 PM

Technical Conference Stage 1, Booth 1076, Exhibit Hall
Language:
English

The audit remarks related to inadequate microbial contamination control and the investigation of discrepancies from 2014 and 2015 by the FDA auditors are increasing and expected to be on the top 10 FDA 483 observations for 2017. Therefore, the presentation will share though different case studies best practice approaches to investigating microbial contamination. Lessons learned from the field on common improper root cause investigation and ineffective CAPA plan will be discussed. Finally, the presentation will share effective investigation approaches to resolving microbial contaminations and when to integrate new/key partner to facilitate the investigation and avoid recurring deviations. The presentation will present the key aspect of an innovative supplier and how this bring plus value to the end-user collaboration. Finally, Recent audit remarks linked to the topics will be shared.

Contributors

  • Walid El Azab

    Speaker

    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...

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. - Understand the benefit to include an external partner and when to do so. 2. - understand a different way of innovative supplier to bring plus value to the end user. 3. - Learn from common mistakes observed from the field to avoid recurring microbial contamination and inadequate root cause investigation

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

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