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Waters Corporation
Firmu Waters založil v roce 1958 pan James Waters. Od té doby se společnost Waters specializuje na kapalinovou chromatografii a hmotnostní spektrometrii. Divize TA Instruments působí na poli termální analýzy. V České republice je Waters zastoupen přímou pobočkou, která sídlí v Praze.
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AQbD Symposium - Day 1 - Concepts and Approaches for Enhanced Method Development

ZÁZNAM | Proběhlo Út, 29.11.2022
Aktualizace pokynů a dopad na odvětví, příklad implementace AQbD MD a způsob, jak zmírnit riziko pomocí MaxPeak High Performance Surface.
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Waters Corporation: AQbD Symposium 2022

Waters Corporation: AQbD Symposium 2022

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:

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

 

Presenter: Phil Borman (Director and Senior Fellow, GSK)

Phil Bormanis a fellow of the Royal Society of Chemistry with over 26 years of experience in the pharmaceutical industry having obtained a Masters in Chemistry from Manchester University, a Masters in Applied Statistics from De Montfort (Leicester) University and a Doctorate in Sciences for his work in pioneering and developing QbD approaches for analytical procedures (also from De Montfort University).

Phil is currently a Director and Senior Fellow at GlaxoSmithKline where he is accountable for the ongoing development and implementation of Quality by Design. Phil pioneered the adaptation of QbD principles to Analytical procedures and has published widely in the field of Analytical Chemistry. He currently co-leads the EFPIA ICH Q2(R2)/Q14 support team as well as being vice-chair of the USP Measurement and Data Quality Expert Committee and member of the BP (MHRA) Analytical Quality by Design Working party.

Development of analytical methods based on the aQbD principles to support pharmaceutical development, commercialization and supply

Presenter: Jinjian Zheng (Sr. Principal Scientist, Merck)

Dr. Jinjian Zheng earned his Ph.D. degree from The University of Tokyo in 1999, and joined Ames-Laboratory, Iowa State University as a postdoc in 2000. He joined Schering-Plough/ Merck in 2003, and is currently a Sr. Principal Scientist at Analytical Chemistry in Development and Supply – Analytical Commercialization Technology.

During his tenure at Merck, Jinjian has served on different roles within Merck across development, commercialization and supply areas. He has established himself as a chromatography SME, and has been promoting aQbD method development at Merck using advanced tools such as chromatography simulation and DOE experimentation.

Jinjian has published 20+ articles in peer reviewed journals, and has given numerous presentations on aQbD method development. He is currently leading the analytical development efforts at Merck to support nitrosamine risk assessment and testing.

Mitigating Risks Associated with Undesired Analyte-Metal Interactions

Presenter: Pankaj Aggarwal (Associate Principal Scientist, Merck)

Pankaj has a PhD in analytical chemistry with over 7+ years of pharmaceutical industry supporting API and DP development across different modalities. Currently, He is working as Associate Principal Scientist at Merck and a scientific supervisor implementing predictive and digital solution for workflow optimization leading to operation excellence and accelerated drug development. Pankaj is passionate about lab automation/digital data analytics and helping teams applying in-silico tools to fundamentally understand LC method performance.

Moderator for the Event Day 1

Presenter: Fadi Alkhateeb (Senior Scientist, Waters Corporation)

Dr. Fadi Alkhateeb is a Senior Scientist in the Scientific Operations Department at Waters Corporation HeadQuarters in Milford, MA USA. He joined Waters in 2017 and since then he has been mainly focusing on exploring various approaches for analytical method development for pharmaceutical drugs. Prior to joining Waters, he was a postdoctoral fellow at the University of Calgary (Calgary, AB, Canada), where he did research at Alberta Sulphur Research, one of North America's leading Sulphur research institutes.

He received his PhD from the University of Calgary, focusing on the development of novel, rapid separation and sample preparation techniques for the analysis of a wide range of chemical compounds. Dr. Alkhateeb published several peer-reviewed articles in top analytical journals.

Waters Corporation
 

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