Particle Measuring Systems

Understanding 21 CFR 11 and Data Integrity Regulations - Webinar


Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. Modern data management systems provide a missing link in such circumstances, allowing secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes. Complying with the new, more demanding requirements and bringing manufacturing processes and control to a new level is a challenge that  cannot neglect full data integrity related standards compliance.

  • How to minimize the risk of non-conformances by understanding your processes
  • The importance of cultivating an ethical approach to data management
  • How to become and stay compliant, and prepare for future standard changes

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.

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