Quality by Design (QbD) for  Analytical Method Development and Validation

Sept. 4, 2013 - PRLog -- Why to attend:

Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.  In addition FDA and international agencies promote the QbD approach because it is expected that such performance based routine methods can be changed within the analytical target profile (ATP) 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 will have the answers. During the seminar, the speaker will go through the new approach and give recommendations for cost-effective method development and validation. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation.

Areas Covered in the Seminar:

* General principles and key benefits of QbD
* Regulatory background and trends: FDA, ICH Q8/9/10
* Reasons for changing the way we validate methods
* Current applications of QbD in the pharmaceutical industry
* The Application of QbD for analytical methods
* Comparison of the QbD process with ICH Q2 and USP <1225>
* Benefits for method transfer and routine use
* Using the lifecycle approach for method design, development and validation
* Using the risk assessment prioritization matrix to select the test parameters
* The timeline for method design, validation and verification
* Using the method in the routine: re-verification and change control
* Documentation requirements
* Defining the Analytical Target Profile (ATP) and design space
* Case studies

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* PowerPoint Presentation
* Script
* SOP: Development and Validation of Analytical Methods through QbD
* SOP: Transfer of Analytical Methods
* Template: Analytical Target Profile for selected HPLC methods
* Template: Design space for selected HPLC methods
* Template: Risk Prioritization Matrix for QbD based Method Validation
* Reference Article: QbD for Better Method Validation and Transfer (link)

Date:  October 31, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Who should attend
* Laboratory managers and staff
* Analysts
* QA managers and personnel
* Regulatory affairs
* Training departments
* Documentation department
* Consultants


Weblink:  http://www.labcompliance.com/seminars/audio/325/default.aspx

Category: Pharmaceutical, Medical device, GMP, API Manufactuer, FDA, Training

Presenter: Dr. Ludwig Huber

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. and he has given multiple presentations and workshops mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included workshops and presentations for the  US FDA, ISPE, PDA, PDA, PIC/S and several national health agencies including China SFDA