Challenges Associated with Validation in Regulatory Environment

About The Event

The last couple of years has seen major revisions to both the US and European pharmacopias in laser diffraction, the pharmacopeia for dynamic light scattering USP<1058> on analytical instrument qualification and ICH Q2 R2 for method development and validation. There is also a laser diffraction good practice document from ISO on the way. What do these documents tell us, and how can we incorporate this guidance into the regulated environment? This webinar will cover the key take home messages from the guidance and provide some practical general advice on method and system validation. This framework will then be picked up in the following talks in the series which cover specific instruments.