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Short Course

Course Information
Course Title: Essentials of Modern HPLC/UHPLC 2: Operation, Troubleshooting and Method Development
Categories: 1 - Life Sciences
2 - Liquid Chromatography
3 - Liquid Chromatography-Mass Spectrometry
4 - Pharmaceutical Sciences
5 - Quality/Regulatory/Compliance
6 - Food
Instructor(s): Michael Dong Course Number: 2
Affiliation: Genentech
Course Date: 03/17/2013 - Sunday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $480 ($680 after 2/18/13) Textbook Fee: $65 (Same text for Course #1)

Course Description
This course will introduce you to best practices of high-performance liquid chromatography (HPLC) and ultra-high-pressure LC (UHPLC) as well as tricks-of-the-trade for successful HPLC operation. The attendees will learn step-by-step guide to operating HPLC modules, maintenance procedures, troubleshooting strategies, traditional and accelerated method development processes as well as recent advances of this pervasive analytical technique including a focused section on ultra-high-pressure LC. This is the second part of a two-course series to modern HPLC introduction. “Essentials of Modern HPLC/UHPLC 1” introduces HPLC fundamental concepts, columns, instrumentations and applications, is a recommended prerequisite for “Essentials of Modern HPLC/UHPLC 2”.

Target Audience
Analysts, scientists, researchers and managers who want to get an updated introduction of modern HPLC practices, instrument operation, maintenance, troubleshooting, method development as well as the practice and issues of UHPLC. Topics covered included operating guide, common maintenance procedures, troubleshooting strategies, HPLC method development processes and ultra-high-pressure LC (UHPLC). The focus is to provide the attendees with a concise overview on the practice of HPLC, helping them to become more successful and effective in HPLC operation, sample analysis, method development and problem diagnosis. A good understanding of general chemistry is recommended. Some prior hands-on HPLC experience would be helpful. “Essentials of Modern HPLC/UHPLC 1” is a prerequisite to “Essentials of Modern HPLC/UHPLC2” for newer users. This course is conducted at an intermediate level.

Course Outline
5. HPLC operation, maintenance and troubleshooting
Mobile phase preparation
Best practice in HPLC operation and avoiding common “faux pas”
Guidelines for increasing HPLC precision and for trace analysis
Seven common “faux pas” in modern HPLC
Common HPLC maintenance procedures
Problem diagnosis and troubleshooting guide with case studies
Diagnosing and solving problems (pressure, baseline, peak, data performance)

6. HPLC method development and validation
Tradition strategy for method development
3-pronged template approach for efficient method development
Method prequalification and validation
Modern trends – software tools and automated systems
Case studies on developing ICH impurity testing of pharmaceuticals including some discussions on phase-appropriate method development and QbD concepts

7. Ultra-high-pressure LC 1 – concepts, perspectives, and benefits
• History and current status of UHPLC
• Practical concepts and instrumental considerations
• Benefits: very fast separation with good resolution, very high resolution of
complex samples, facilitating rapid method development
• Case studies (NCE, OTC, complex molecules and natural products)

8. Ultra-high-pressure LC 2 – practice, potential issues and QC implementation
• Potential issues and operating nuances (viscous heating, system dispersion, compatibility to existing methods, injection precision and carryover, detector sensitivity and dwell volumes, and method transfer issues)
• Case studies illustrating issues and myths, and how to mitigate potential pitfalls
• How to get started and to transition from HPLC to UHPLC

Course Instructor's Biography
Dr. Michael W. Dong is a Senior Scientist at Genentech, Small Molecule Drug Discovery, South San Francisco, CA. He is responsible for new technologies, automation and supporting multiple late-stage research projects in Small Molecule Analytical Chemistry and QC, Small Molecule Pharmaceutical Sciences. He was formerly Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, Senior Staff Scientist at Applied Biosystems / Perkin-Elmer, and section-head in Hoechst Celanese. He holds a Ph.D. in Analytical Chemistry from City University of New York, and a certificate in Biotechnology at U. C. Santa Cruz. He has conducted training courses at national meetings (ACS, Pittcon, EAS, and HPLC) on HPLC in pharmaceutical analysis and DMPK, HPLC method development, ultra-high-pressure LC, drug development process for scientists, and drug quality fundamentals. He has over 80 publications in chromatography and analytical chemistry. He authored a best-seller in chromatography - Modern HPLC for Practicing Scientists, Wiley, 2006 and co-edited Handbook of Pharmaceutical Analysis by HPLC, Elsevier/Academic Press, 2005. He is an editorial advisory board member of LC.GC magazine and American Pharmaceutical Review.