2012 - Quality by Design (QbD) for Development and Validation of Analytical Methods

This seminar will discuss how design robustness of analytical methods for easy transfer and to avoid OOS situations
Why to attend:
Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method method transfer and fewer or no methods specific Out-of-Specification situations when used in rotine. In addition FDA and international agencies promote the QbD approach because once accepted performance based routine methods can be changed without regulatory resubmission and approval Because there is no or little experience with the QbD approach for analytical methods the industry has many questions. This seminar answers the questions.
Areas Covered in the Seminar:
* General principles and key benefits of QbD
* Regulatory background and trends
* Current applications of QbD in the industry
* The Application of QbD for analytical methods
* The 4-stage process of QbD for method design, development and validation
* Comparison of the QbD process with ICH Q2 and USP <1225>
* Using the risk assessment prioritization matrix to select the test parameters
* Benefits for method transfer and routine use
* Using the lifecycle approach for method design, development and validation
* The timeline for method design, validation and verification
* Documentation requirements
* Defining the Analytical Target Profile (ATP) and design space
* Case studies
Date: January 26, 2012
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide
Who should attend
* Laboratory managers and supervisors
* GLP and GMP auditors
* QA/QC managers and personnel
* Analysts and other laboratory staff
* Regulatory affairs
* Documentation department
* Training departments
* Consultants
Weblink: http://www.labcompliance.com/seminars/audio/283/de...
Presenter: Dr. Ludwig Huber
Category: Pharmaceutical, FDA, validation