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Analytical Method Transfer of Pharmaceutical Products

Type	Course
Language	English
Date	April 10, 2008 from 08:25 am to 05:00 pm
Venue	Doubletree New Orleans 300 Canal St New Orleans, LA 70130 US
Chemistry Specialties	analytical chemistry drug design and discovery other
Chemistry Techniques	other
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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by Lilach Zuriel — last modified 02-13-08 09:33 AM

Analytical methods are a major tool in the pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are normally developed at one site and then transferred to one or more sites during the drug development process. Qualifying analysts to perform these methods is a critical activity that would significantly impact the launch of a product. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site to another or one department to another. This course will present fundamental principles of a method transfer, examine different strategies, discuss key factors that would influence the transfer of analytical methods from one site to another. Registrants will receive a copy of Modern HPLC for Practicing Scientists, by Dong (Wiley-Interscience, 2006) with their registration.

Key Topics * Planning and developing an effective transfer protocol * Exploring key process steps that are site dependent * Selecting appropriate strategies for method transfer * Providing a framework to improve the success of method transfer * Understanding method capabilities to set acceptance criteria

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 offer.

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