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Particle Measuring Systems
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Quality Risk Management in Pharmaceutical Industry

Case Study: Developing an Isolator Filling Line Using Quality Risk Management in Pharmaceuticals

Quality Risk Management in Pharmaceutical IndustryFollowing the patent of the “Espresso” innovative infusion device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a new isolated filling line. Particle Measuring System’s Contamination Control Advisory Team oversaw the development of the aseptic filling process and the environmental monitoring system of this project by applying proven quality risk management techniques. Using this case study we will  provide practical insights for Quality by Design principles.

Key Learning Points

  • Project Management Theory
  • Project milestone examples
  • Analyzing, reviewing, and improving processes
  • Process steps risk analysis and mitigation
  • Defining air and surface critical sampling points
  • Using risk management tools (FMEA, Fishbone, HACCP)
  • FAT/SAT and validation approach

COMPLETE THE FORM TO ACCESS THIS ON-DEMAND WEBINAR 

Particle Measuring Systems (PMS) has complete contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
  • Cleanroom particle counters including portable/mobile and fixed/remote
  • Microbial Monitors including portable/mobile, fixed/remote, and single use.
  • Data management software

We are direct in every major market and able to ensure the same ongoing support no matter where you are located. Request a quote now.

  • Speaker

    Sr. Daniele Pandolfi

    Gerente Global de Linha de Produtos, Software/Sistemas/Serviços, Particle Measuring Systems, Inc.

    Daniele Pandolfi é o Gerente Global de Linha de Produtos de Software/Sistemas/Serviços da Particle Monitoring Systems, Inc. Com mais de 11 anos de experiência em contador de partículas e controle de contaminação em salas limpas, ele se concentra em construir e manter relacionamentos fortes com os clientes. Ele ajudou muitos usuários de salas limpas a resolver seus problemas de cGMP.

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Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Compressed Gases Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Industrial Manufacturing

Applications

  • ISO 21501-4
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • PMS™ Knowledge Center
  • Software / Data Management
  • Contamination Monitoring Blog

About Us

  • Contact Us
  • Why PMS
  • Executives
  • Particle Measuring Systems’ Careers
  • Corporate Responsibility, Sustainability, Health & Safety
  • COBE
  • Parent Company
  • Press Releases
  • Credibility & Registrations
  • Trademarks & Patents

Particle Measuring Systems- DK

Particle Measuring Systems Nordic
Korskildelund 4-6
2670 Greve, Denmark

T. +45 7070 2855
[email protected]

Keep in touch! Receive industry news from us:

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