North Jersey Chromatography Group



NJCG May In-Person Dinner and Seminars on

Risk Mitigation in the Pharmaceutical Analytical Laboratory

May 23, 2023

Double Tree Hotel, Somerset, NJ

5:30-8:30 PM

Cost: $15.00 with Dinner
(5:45 PM)

Seminars only: Free (arrive at 6:20 PM)




Tuesday, May 23, 2023


Dinner


5:45 PM

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Presentations



6:30 PM

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Phase-Appropriate Implementation of aQbD

Method Development



JinJian Zheng

Merck


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7:10 PM




A Risk-Based Approach to Method Migration and Transfer


Amanda Dlugasch

Waters Corporation


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7:50 PM


Discover Intuitive Simplicity in HPLC


Denise Heyburn

Waters Corporation

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Phase-Appropriate implementation of aQBD Method Development



Dr.JinJian Zheng (Presenter)

This presentation will discuss the development of analytical methods using the aQbD principles described in USP <1220> and ICH Q12/Q14/Q2(R2). Several examples across different stages of pharmaceutical development will be used to demonstrate a systematic and efficient approach for method development in order to 1) improve data quality (specificity, accuracy and precision) and 2) to improve method robustness and enhance method understanding in order to minimize method failure and promote efficient communication between applicant and regulatory agencies. Topics will include: • How to design and develop a robust method based on sound scientific understanding of the samples of interest • How to use advanced tools to improve the efficiency of method development, e.g. calculation of physicochemical properties such as pKa, LogD, solubility, boiling point (for GC) etc. automated DOE experimentation chromatographic modelling • How to develop practical analytical solutions based on sound scientific principles, and with line of sight for commercial support



A Risk-Based Approach to Method Migration and transfer



Amanda Dlugasch (Presenter)

Moving methods across different LC systems can pose challenges, especially when atypical method conditions are encountered or conditions that are beyond the typical operating range of an LC system. In this presentation, experts in instrumentation will review the design differences that can impact method migration across a variety of systems and outline an approach to control for these variables. The presentation will review some common differences and how to reduce errors in set up and operation.


Discover Intuitive Simplicity in HPLC



Denise Heyburn (Presenter)

Be the first to discover a new HPLC designed specifically to address the unique challenges faced by quality control (QC) labs The pressures pharmaceutical QC labs face today are immense, like doing more with less, faster turnaround times, and ever-increasing regulatory requirements. What if your HPLC could bring smart quality into your daily routine, making it easier for you to do the important work you already do more quickly and efficiently? Find out how our new HPLC addresses common QC lab challenges:

• Rising costs

• Human errors

• Failed batches

• Increasing regulatory scrutiny




Jinjian Zheng



Senior 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.



Amanda Dlugasch



Senior Scientist
Waters Corporation



Amanda Dlugasch is a Senior Scientist in the QA/QC Strategy and Growth Department at Waters Corporation in Milford, MA. She received her B.A. in Chemistry from Manhattanville College and her M.S. in Chemistry from Sacred Heart University. She started at Waters Corporation in the Instrument Evaluation group developing qualification protocols for newly released products. Upon transferring to the QA/QC Strategy and Growth Department, her initial focus was to evaluate and provide application and training material for the release of ACQUITY Arc UHPLC System. She studied how LC instrument design and LC system characteristics influence chromatography when transferring, scaling and modernizing methods. Currently, she is working on evaluating the Alliance iS HPLC System.



Denise Heyburn



Senior Technical Support Specialist
Waters Corporation



In this role as applications chemist for Waters for the last 18 years, Denise demonstrates new Waters products and instrumentation, trains customers on hardware and software, gives educational seminars, and supports customer applications using Waters products. Prior to working at Waters Corporation, Denise was employed mostly by pharmaceutical and biotechnology companies such as J&J Pharmaceutical R&D and 3-Dimensional Pharmaceuticals, working as an analytical chemist supporting medicinal chemistry. Denise has also worked in GLP environments. She has experience with both large and small molecules on LC, LC/MS, SFC and UPLC. Denise has a Masters Degree in Chemistry from Rutgers University. .





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