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Introduction to Photostability
A Practical Introduction to
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Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices
| Type | Course |
|---|---|
| Language | English |
| Date |
April 8, 2008 from 08:30 am to 05:00 pm |
| Venue |
Westin New Orleans Canal Place 100 Rue Iberville New Orleans, LA 70130 US |
| Chemistry Specialties |
|
| Chemistry Techniques |
|
| Contact |
ACS 1155 Sixteenth Street, NW Washington, DC , 20036 US 1-800-227-5558 ext. 4508 202-872-6336 service@acs.org |
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Stability program plays a pivot in pharmaceutical development. Stability-indicating methods are utilized to determine the quality of the drug product throughout its shelf life. A sustainable stability program in compliance with current regulations is therefore critical to development of new pharmaceutical products. This short course introduces a comprehensive overview of FDA and ICH stability requirements for New Chemical Entity (NCE). The technical aspects and analytical methodologies are discussed together with the latest regulations and guidelines. Registrants will receive a copy of Modern HPLC for Practicing Scientists, by Dong (Wiley-Interscience, 2006) with their registration.
Key Topics
* Overview of stability role in the drug development process
* Examine factors that may affect expiration dating of drug products
* Review cGMP and ICH stability requirements
* Discuss impact of global stability requirements
* Develop stability indicating analytical methods
* Design forced degradation studies for HPLC analyses
* Review warning letters and recent citations
Speakers
Kim Huynh-Ba is the Technical Director of Pharmalytik 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.
Kim has authored numerous technical publications and is invited as a frequent speaker at national and international conferences. Since 2001, she has conducted training activities on cGMP compliance and quality issues for national organizations such as ACS, AAPS, IIR, SWE, IVT and CBI. She is also the founder of the AAPS Stability Focus Group, and is an active member of AAPS, PSDG, as well as serving on the Governing Board of Eastern Analytical Symposium (EAS). She also is EAS 2008 Short Course Chair and AAPS 2008 APQ Distance Learning Chair.
Cost
Member - $895
Academic Member - $447.50 Note: This discount is only available if you register by fax, mail or phone and mention this discount and may not be combined with any other offer.
Non-member - $995
Early Registration - Register before March 3, 2008 for the ACS Spring National Meeting Short Courses and receive $100 off the standard member/nonmember fees.
Late Registration - Registrations after March 31, 2008 for the ACS Spring National Meeting Short Courses will be assessed a $100 administrative fee.
Group Rate - Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax, mail or phone and mention this discount and may not be combined with any other of