Practical HPLC for Pharmaceutical Analysis
Kim Huynh-Ba, Instructor
Monday May 5, 2008
Mason Business Center — P&G
8700 Mason-Montgomery Road, Mason Ohio
Who Should Attend:
This course focuses on reversed-phase analysis of drug substances and drug products (small molecule). It is designed for managers and researchers who currently use, supervise, or need to learn more about HPLC method development and method validation in a pharmaceutical or regulated (cGMP) laboratory. To get the most out of the course, it is highly recommended that you have at least two years of hands-on HPLC experience.
Key Topics You’ll Learn About:
Conduct method validation by phases of development
Maintain validation through method life cycle
Discuss regulatory expectations through warning letters
How You’ll Benefit from this Course:
Become more successful in pharmaceutical assays and ICH impurity testing
Learn method development strategies
Learn key concepts in reversed-phase HPLC
Understand regulatory aspects for HPLC assays
Design your method validation in compliance of regulations
Monitor impurities according to ICH guidelines
About the Instructor:
Kim Huynh-Ba is the Technical Directory of Pharmalytic Consulting and Training Services (www.pharmalytik.com). With over twenty years of experience in various analytical areas of pharmaceutical development and a primary focus in stability sciences, she specializes in analytical development, stability, outsourcing and technology transfer management. She has been involved with several projects harmonizing and optimizing analytical best practices in several companies, including those under Consent Decree.
Program Agenda:
Check-in will begin at 7:45 am. The course will be taught from 8:00am to 5:00pm. If you have technical questions about the course, contact Kin Huynh-Ba at kim.huynhba@pharmalytik.com.
Date and Site:
May 5, 2008, this is a 1-day course. Location: Mason Business Center (formerly Health Care Research Center) — The Procter & Gamble Company, 8700 Mason-Montgomery Road, Mason, Ohio 45040.
Registration and Fees: REGISTRATION IS NOW CLOSED. The course fee will be $500 for ACS members and $600 for non-members (compare to $895/$995 at the National ACS meeting). The fee includes course materials, continental breakfast, lunch, and refreshment break, and a copy of Modern HPLC for Practicing Scientists, by Dr. Michael Dong (Wiley-Interscience, 2006). Seating will be limited.
To Pay by Check:
Make check payable to: “Cincinnati Section ACS” and send to
Dr. Rick White
The Procter and Gamble Company
Mason Business Center
8700 Mason-Mongtomery Road
Mason, OH 45040