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Analytical Method Transfer of Pharmaceutical Products |
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| Course Code: METR |
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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 need to purchase a copy of Handbook of Stability Testing of Pharmaceutical Products: Regulations, Methodologies and Best Practices by Huynh-Ba (Springer, 2008) in addition to registration. |
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Date - TBA |
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Check-in opens at 7:30 a.m. on the first day of the course.
Course runs from 8:30 a.m. to 5:00 p.m. each day. |
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TBA |
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Early Registration: |
$795 |
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Advanced Registration: |
$895 |
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Standard Registration: |
$995 |
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The course fee includes a course binder and a continental breakfast each day.
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 or mail and mention this discount. May not be combined with any other offer. |
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- 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
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| Kim Huynh-Ba is a Technical Director at Pharmalytik Consulting and Training Services. She teaches Advanced HPLC in Pharmaceutical Analysis; Analytical Method Transfer of Pharmaceutical Products; Stability Testing in Pharmaceutical Development; Practical HPLC in Pharmaceutical Analysis. She is the editor of “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (Springer 2008) and “Pharmaceutical Stability Testing to Support Global Markets” (Springer 2009). |
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