Implementing the New USP Chapter <1224> for Analytical Method Transfer 2012

March 15, 2012(Ended)

Online Webinar

Implementing the New USP Chapter <1224> for Analytical Method Transfer 2012

Implementing the New USP Chapter `1224` for Analytical Method Transfer is a webinar that covers topics such as:

Examples of FDA warning letters and how to avoid them
FDA and International expectations for method transfer
The proposal for a new USP chapter `1224`: history, status, future
The FDA Guidance on method transfer
Selecting the best approach
Four approaches for analytical method transfer and testing
Developing a transfer plan and a pre-approval protocol
Responsibilities of the transferring and receiving laboratory
Criteria and approaches for risk based testing: what, when, how much?
Conducting comparative studies
Dealing with technology transfer: validation requirements, regulatory notification
The importance and selection of acceptance criteria
Most likely failures during method transfer
Method transfer from standard HPLC to UHPLC
Criteria for transfer waiver (omission of formal transfer)
Handling deviations from documented acceptance criteria
Method transfer protocol and summary report

Implementing the New USP Chapter `1224` for Analytical Method Transfer brings together QA managers and personnel, attendees involved in method transfer, Validation specialists, Analysts and lab managers, Documentation department, Training departments and Consultants.

Prices *

149-399 US Dollar

Organization

Labcompliance

Website

www.labcompliance.com/seminars/audio/286/default.aspx

Categories Click on a category for similar events