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

Overview:

Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.

In addition FDA, USP 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. This seminar will give a good understanding of QbD for analytical methods and provide recommendations for implementation. .

For Easy Implementation, Attendees Will Receive:

• SOP: Development and Validation of Analytical Methods through Quality by Design
• Master plan - Template and examples: Development and Validation of Analytical Methods through QbD

Areas Covered in the Session:

• General principles and key benefits of QbD
• Regulatory background and trends: FDA, ICH Q8/9/10
• The Application of QbD for analytical methods
• Reasons for changing the way we validate 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
• Defining the Analytical Target Profile (ATP) and design space
• Using the risk assessment prioritization matrix to select the test parameters
• Multivariate experimental design to select the parameter range
• The timeline for method design, validation and verification
• Using the method in the routine: review, revalidation and change control
• Recommendations for implementation

Who Will Benefit:

• Method development groups
• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Regulatory affairs
• Human resources (HR) managers and staff
• Documentation department
• Consultants