Analytical Method Transfer of Pharmaceutical Products
| Type |
Course |
| Language |
English |
| Date |
August 18, 2009
from
08:30 am
to
05:00 pm
|
| Venue |
Crowne Plaza Hotel - The Hamilton
1001 14th St NW
Washington,
DC
20005
|
| Chemistry Specialties |
|
| Chemistry Techniques |
|
| Contact |
American Chemical Society
1155 Sixteenth Street, NW
Washington,
DC
20036
US
(800) 227-5558
shortcourses@acs.org
|
| Add event to calendar |
vCal (Windows, Linux)
iCal (Mac OS X)
|
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.
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
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.
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. With over 20 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.
Session titles
Overview of the Method Transfer Process
* Purpose of Analytical Method Transfer
* Strategies of Method Transfer
* Phases of Method Transfer
* Determine Gap Analysis
Preparation Phases of Method Transfer
* Contents of method transfer package
* Training options involving method transfer
* Determine impacts on the transfer process
Establishing Method Transfer protocol
* Developing Method Transfer protocol
* Determine acceptance criteria
* Evaluating and documenting transfer data
Key Factors impacting Method Transfer
* Exploring key process steps that are site dependent
* Understanding method capabilities to set acceptance criteria
* Investigating method transfer failures
More information about this event…
Forgot your password?
New user?
Introduction to Photostability
A Practical Introduction to
