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Particle size and 21CFR Part 11 - Data integrity with your Mastersizer 3000

Live Webinar November 21st, 2018

In this webinar Sarennah Longworth-Cook will discuss the issues involved with data integrity, using the Mastersizer 3000 as an example. This will include an overview of the Malvern security system, which provides user access control and 21 CFR Part 11 compatible audit capability, as well as discussion of the application of 21 CFR Part 11 to laser diffraction.

Laser diffraction is a powerful technique for measuring particle size rapidly and with statistical significance. The particle size parameter is a critical indicator of process consistency and product quality in many industries. These two factors have led to widespread adoption of laser diffraction for quality control or quality assurance purposes. In the QC/QA environment, there may be additional requirements around user access and data integrity, in order to ensure the quality of the data itself is high and that this is recorded in an audit trail. The requirements for the most robust levels of data integrity are described in 21CFR Part 11.

Who should attend?

• Supervisors and lab managers with responsibility for user control, data integrity or 21CFR Part 11 implementation for Mastersizer 3000.

What will you learn?

• Appreciation of data integrity issues related to laser diffraction systems. The application of 21CFR Part 11 to a Mastersizer 3000 to achieve compliance.

You can register for free to all our webinars and you will automatically receive the On Demand version

Details

  • Malvern WR14 1XZ, UK
  • Malvern Panalytical