Dr. Lee Polite 
"Requested Development: How to Create an HPLC method from Scratch"

ABSTRACT

There are more than 1 million HPLC’s in the world.  Which means there are 1 million people standing in front of HPLC’s pushing buttons.  Unfortunately, most of them have no idea why they’re pushing those buttons.  In this talk, I will attempt to unveil these mysteries to you about how HPLC really works.  And more importantly, how you can use that knowledge to develop even complex methods from scratch, employing a simple, structured approach.  Of course, there will be Kool-Aid involved!

Kim Huynh-Ba
"Building Analytical method validation through science, risk, and lifecycle framework"

ABSTRACT

Analytical method validation is a core component of pharmaceutical quality systems, ensuring analytical data support product quality, safety, and efficacy. Regulatory expectations now emphasize a science-based, risk-informed, and lifecycle-oriented approach, moving validation beyond a one-time compliance activity.

This presentation highlights how clear analytical objectives, method understanding, and risk assessment define fit-for-purpose validation strategies. Key validation characteristics—including specificity, accuracy, precision, linearity, robustness, and detection capability—are discussed in the context of enhanced statistical rigor and lifecycle management. The link between development knowledge, validation decisions, and effective change management is emphasized. Applying science, risk, and lifecycle principles improves method robustness, supports efficient change control, and strengthens regulatory confidence over the method lifecycle.

PROGRAM

Menu

Buffet Style Menu:
Traditional Greek Buffet with a vegetarian option too
Dessert
Assorted soda/sparkling water
Wine/Beer

Parking

Parking is 1/2 block from Axion Labs at Peoria and Washington
The self-pay kiosk fee is $20, Axion will reimburse $10 before your departure. 
Park One 850 W. Washington, Chicago, IL 60607

Deadline to register: Monday, February 23rd at Noon.

Door prize

QUESTIONS?

QUESTIONS?  Please contact the Section Office via phone (847-391-9091) or email ([email protected]).

BIOGRAPHY

Dr. Lee Polite

Dr. Lee Polite earned his Ph.D. in Chemistry from Virginia Tech under the guidance of Professor Harold McNair, a pioneer in chromatography. Lee also holds a bachelor’s degree in chemistry from DePauw University and an MBA from Northwestern University. He has been teaching chromatography (GC and HPLC) to scientists and engineers for over 30 years.

In 1995, Dr. Polite established the Axion Training Institute to offer hands-on HPLC and GC training to chromatographers worldwide. Since then, he has instructed over 14,000 professionals, including staff from top pharmaceutical, chemical, and petroleum companies in the U.S., as well as numerous government agencies such as the DEA, FBI, FDA, EPA, Homeland Security, and more than 500 lawyers and judges!

Lee has served as a National Instructor of Chromatography for the American Chemical Society (ACS) since 1991, and he remains one of the top-rated instructors. He is the President of Axion Analytical Laboratories, an adjunct chemistry professor at Illinois Institute of Technology (IIT), and actively shares his passion for chromatography whenever possible.

Kim Huynh-Ba

Kim Huynh-Ba is the Managing Director of Pharmalytik, bringing nearly three decades of experience in pharmaceutical quality systems, strategic drug development, CMC, analytical development, and stability. She advises global organizations on GxP compliance and teaches graduate-level courses on pharmaceutical development as an Adjunct Professor at IIT and Temple University School of Pharmacy. She is also a Short Course Instructor of ACS, EAS, USP, ICH, CfPIE, Pittsburgh Conference.

She is a member of the US Pharmacopeia (USP) Biologics Expert Committee and served on the USP Council of Experts from 2015 to 2025. She also serves on the Governing Board of Directors of the Eastern Analytical Symposium (EAS) and was its President in 2013. She was named an AAPS Fellow in 2020 and received the EAS Distinguished Service Award in 2021. Kim has published over 50 peer-reviewed articles and book chapters, edited leading stability references, and remains actively involved with USP, AAPS, and EAS.

Tickets

$20.00 REGISTRATION: Chicago ACS member

$20.00 Non-Chicago ACS member Students, Post Docs, Guests

$0.00 Member Virtual-Only

$0.00 Non-Member Virtual-Only

$20.00 Non-Chicago ACS member Students, Post Docs, Guests