Impress your boss with this course

In this webinar, Dr. Michael W. Dong, Pittcon Short Course Instructor, will review best practices, short cuts, and tricks-of-the-trade to help pharmaceutical and other scientists to become more successful in developing effective HPLC methods (potency and ICH-compliant stability-indicating assays) using method templates and universal generic gradient methods.

Dr. Michael W. Dong, MWD Consulting

This 2-hour intermediate webinar reviews best practices, short cuts, and tricks-of-the-trade to help pharmaceutical and other scientists to become more successful in developing effective HPLC methods (potency and ICH-compliant stability-indicating assays) using method templates and universal generic gradient methods.

VIEW COURSE AGENDA

Who Should Attend?
This workshop is intended for analysts, managers, and researchers using HPLC in the pharmaceutical laboratory wishing to learn how to develop HPLC methods quickly and more effectively. A fundamental understanding of HPLC is assumed and some practical hands-on HPLC experience is highly recommended.

Recommended Textbook:
HPLC and UHPLC for Practicing Scientist – LEARN MORE

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Webinar Agenda

  • A. The Traditional Method Development Approach
    a.) Glossary, Insights, Steps in traditional method development, Scouting gradient and getting the first chromatogram, method fine-tuning and optimization (Solvent strength/type, pH, buffer/additive, F, T, tG), Case studies for method development of a phase 0 method for a new chemical entity

    b.) General method development strategy, forced degradation studies to demonstrate method specificity, automation screening systems and software tools

    a.) Fast LC isocratic methods for potency or performance assessment,
    generic broad-gradient methods, Multi-segment gradient methods for ICH compliant stability-indicating assays of complex molecules, case studies of multichiral drugs and complex products with multiple APIs, referencesa.) Introduction of a universal generic gradient method(s), method is capable of peak capacities of 100-300 in 2 to 6 minutes, Rationales of selection of column and operating conditions (CSH, SPP, tG), method adjustments, Case studies for cleaning verification of multiple NCEs, purity assays including compounds with multiple chiral centers

Dr. Michael Dong Bio

Dr. Michael W. Dong is a principal in MWD Consulting focusing on training and consulting services in HPLC/UHPLC, pharm analysis, and drug quality. He was formerly Senior Scientist at Genentech, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems / Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from City University of New York, and a certificate in Biotechnology at U. California. Santa Cruz. He has over 120 publications and a best-seller book in HPLC. He is an advisory board member of LCGC magazine, American Pharmaceutical Review, and Chinese American Chromatography Association.

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