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Short Course

Course Information
Course Title: HPLC/UHPLC Method Development Made Easy
Categories: 1 - Life Sciences
2 - Liquid Chromatography
3 - Liquid Chromatography-Mass Spectrometry
4 - Management/Professional Development
5 - Pharmaceutical Sciences
6 - Quality/Regulatory/Compliance
Instructor(s): Michael Dong Course Number: 14
Affiliation: MWD Consulting
Course Date: 03/06/2017 - Monday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $325 ($425 after 2/18/17) Textbook Fee:

Course Description
This 1/2-day workshop reviews best practices, short cuts and tricks-of-the-trade to help the pharmaceutical or other analytical scientists to become more successful in developing effective HPLC/UHPLC methods (potency and ICH-compliant stability-indicating assays) using the traditional approach, a 3-pronged method template approach, a universal generic gradient method(s) and a QbD approach using automation and statistical software tools.

Target Audience
This workshop is intended for analysts and researchers using HPLC or UHPLC in the pharmaceutical and other laboratories wishing to learn how to develop HPLC methods quickly and more effectively using the traditional and other expedited approaches. A fundamental understanding of HPLC is assumed and some practical hands-on HPLC experience is recommended.

Course Outline
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, method development trends, Phase-appropriate method development, development of secondary “orthogonal” methods, automation screening systems and software tools, Fusion QbD.
B. The 3-Pronged Template Approach for Rapid Method Development
a. Fast LC isocratic methods for potency or performance assessment,
generic broad-gradient methods for in-process control, high-throughput screening, purity assays of starting materials and cleaning verification
Multi-segment gradient methods for ICH compliant stability-indicating assays of complex molecules, case studies of multichiral drugs and complex products with multiple APIs, references
C. A Modern Universal Generic Gradient Method(s):
a. Introduction of a universal generic gradient method(s), This fast LC method is capable of peak capacities of 100-300 in 2 to 5 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.
D. Quality by Design (QbD) Approach to method development:
a. Introduction to QbD, Design of Experiments (DoE), and ICH Q8(R2), QbD approach to HPLC method development using S-Matrix Fusion QbD software platform
b. Case Studies 1 to 4 illustrating workflows and results

Course Instructor's Biography
Dr. Michael W. Dong is a principal consultant in MWD Consulting focusing on consulting and training services on HPLC/UHPLC, pharmaceutical analysis and drug quality. He was formerly Senior Scientist in Analytical Chemistry and Quality Control at Genentech, Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems / Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from the City University of New York, and a certificate in Biotechnology from U. C. Santa Cruz. He has 100+ publications including a bestselling book on chromatography (Modern HPLC for Practicing Scientists). He is an editorial advisory board member of LCGC magazine and American Pharmaceutical Review. Recommended textbook: M. W. Dong, Modern HPLC for Practicing Scientists, Wiley-Interscience, New Jersey, 2006 (ISBN-10: 047172789X).