Event Detail
“Analytical Method Transfer of Pharmaceutical Products”
June 16 - 23, 2008
- Online DE UNITED STATES
BenAstrum Pharma Broad
info@benastrum.com
Phone: 514 337 1616
Fax: 514 337 8803
Analytical methods are a major tool used in 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 will 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 or department to another. This 2-session webinar series will present fundamental principles of a method transfer, examine different strategies, and discuss key factors that will influence the transfer of analytical methods from one site to another. Discussion Points: Session 1: Understanding Method Transfer Process Purpose of Analytical Method Transfer Strategies of Method Transfer Phases of Method Transfer Contents of Method Transfer package Determine impacts on the Transfer process Session II: Establishing Method Transfer Protocol Selecting a Method Transfer team Developing Method Transfer protocol Determining appropriate acceptance criteria Evaluating and documenting Transfer data Handling investigations of Transfer failures