Understanding ISO 14644-1/2:2015 and Becoming Compliant

Understanding ISO 14644-1/2:2015 and Becoming Compliant

03/22/2017, 1:15 PM - 2:00 PM

Meeting Room 4

Language:
English

In the new era of "high technology manufacturing", pharmaceutical manufacturers are increasingly pushed to improve their production efficiency, product quality/quantity and reduce the time to release in order to be competitive. Achieving this target is a challenge that cannot neglect full ISO Standards Compliance. The "Understanding ISO 14644-1/2:2015" presentation will teach those new to particle contamination control basic terminology understanding. Advanced users will get a detailed interpretation of the primary standard for cleanroom classification and monitoring. Also, specific focus will be dedicated to the most relevant changes of the latest ISO 14644-1/2 standard revision. Learn more about: -The best practices to adopt for a controlled and certified production environment -How to minimize the risk of non-conformances -How to maximize your production capabilities using the right technology solution -How to become and stay compliant, and prepare for future standard changes

Contributors

  • Daniele Pandolfi

    Speaker

    Product Line Manager - Life Science

    Particle Measuring Systems

    Daniele Pandolfi Particle Measuring Systems - Life Science Division Global Product Line Manager, Aerosol dpandolfi@pmeasuring.com Daniele Pandolfi...

Documents

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. • The best practices to adopt for a controlled and certified production environment o (Classification Methodology according to ISO 14644-1:2015) 2. • How to minimize the risk of non-conformances by understanding your process and cleanroom performance o (Quality by Design, risk assessment and trend analysis – ISO 14644-2) 3. • How to maximize your production capabilities using the right technology solution o (On-Line / Off-Line Facility Monitoring System) • How to become and stay compliant, and prepare for future standard changes.

Categories

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

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