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Pharma Data Management for Root Cause Identification in Critical Environments (Case Study)

Pharma Data Management for root cause analysisWith the increasing use of sophisticated Pharma Data Management software, the collection and evaluation of data has never been easier. However, managing such a large amount of information can present a challenge, potentially becoming an obstacle to effectively and quickly identify the root cause of the environmental OOS associated deviation.  In this on-demand webinar you will learn the best practices to effectively approach a complete investigation with the support of an Environmental Monitoring Data Management software, combining the traditional investigation methods with the enhanced capabilities of analysis provided by the software-based solution.

Topics covered in this webinar:

  • Case study overview
  • How to perform the full-scale OOS investigation
  • How to collect and manage data with PharmaIntegrity
  • Investigation module
  • Remediation (CAPA) plan

Ready to tackle your root cause analysis? Particle Measuring Systems can help:

  1. Our Cleanroom Controls Advisory Services can provide you with guidance and insights
  2. PharmaIntegrity data management software connects with your data collectors and provides 21CFR11 insights.
  • Speaker

    Maurizio Della Pietra, MPhys

    Associated Product Line Manager for Life Science Services, Particle Measuring Systems

    Maurizio collaborates and consults with pharmaceutical companies and with developers of pharmaceutical equipment and isolation technologies for improving the sterility assurance on science-based strategies. He also is the EMEA Field Application Specialist for Data Management and Analysis. He has a strong background in QA processes, validation of equipment, utilities, facilities, computer systems, data and production processes and aseptic production processes and statistical analysis of them.

  • Speaker

    Anna Campanella, PhD

    Advisory Team Head, Particle Measuring Systems

    Anna has vast industry experience which she uses to collaborate and consult with pharmaceutical companies. She is highly skilled in the development and implementation of science-based strategies, principles of contamination monitoring, and methods of controlling and improving the chemical, physical, and microbiological states of various production processes. Anna holds a PhD in Molecular Medicine and is an authority in many areas of pharmaceutical manufacturing; such as: QA & QC processes, validation of chemical and microbiological methods and the validation of sterile production processes. Additionally, she maintains expert-level knowledge of the microbiological aspects of aseptic production processes.

  • Presenter

    Daniele Pandolfi

    Global Product Line Manager, Aerosol, Particle Measuring Systems

    Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization in 2015.