AQbD or Analytical Quality by Design is an approach to analytical method development that “starts with the end in mind”.

Regulators welcome this science and risk-based approach as described in several guidelines from ICH, USP, and BP. Using the preferred language of regulators when filling applications for both small and large molecules, synthetic or biological drugs can significantly reduce the time-to-market.

Learn about general concepts and approaches to AQbD that are outlined in the upcoming ICH Q14 and USP <1220> chapters and how industry leaders and Waters are tackling these exciting workflows guaranteed to reduce risk and produce robust methods across your organization. 

Join us on Tuesday, November 29 and hear from experts in the Pharma arena to receive an update on the guidance, and the impact for the industry, an example for the phase-appropriate implementation of AQbD method development and a how to mitigate risk using the MaxPeak High Performance Surface. 

Followed by a live panel discussion with all the speakers. So have your questions ready!

Confirmed Speakers on 29 Nov:

• Phil Borman, GSK
  Analytical Procedure Development & Validation – ICH Q14, ICH Q2 (R2) & USP <1220>

• Jinjian Zheng / Pankaj Aggarwal, Merck
  Development of analytical methods based on the aQbD principles to support pharmaceutical development, commercialization and supply

• Fadi Alkhateeb, Waters Corporation
  Mitigating Risks Associated with Undesired Analyte-Metal Interactions

• Isabelle VuTrieu, Waters Corporation
  Moderator for the Event Day 1
  
  
  
  

 

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