The Quality by Design (QbD) for Development and Validation of Analytical Methods is a webinar that covers topics such as:
- Regulatory background and trends
- General principles of QbD
- The Application of QbD for analytical methods
- Current applications of QbD in the industry
- Benefits for method transfer and routine use
- Comparison with ICH Q2 and USP
- The timeline for method design, validation and verification
- Using the lifecycle approach for method design, development and validation
- Defining the Analytical Target Profile (ATP) and design space
- Documentation requirements
- Case studies
The Quality by Design (QbD) for Development and Validation of Analytical Methods brings together:
- GLP and GMP auditors
- Laboratory managers and supervisors
- Analysts and other laboratory staff
- QA/QC managers and personnel
- Documentation department
- Regulatory affairs
- Consultants
- Training departments
