This course will cover key elements and scientific considerations that are important for successful analytical test procedure development and validation for biologics. The course will also provide guidance for verification of USP compendial procedures. The importance of critical quality attributes (CQAs) and selection of procedures which are fit for purpose will also be covered. The development of robust and reliable analytical procedures with appropriate system suitability criteria will be presented using multiple case. Step-by-step validation guidance will be discussed along with the key consideration factors using recombinant protein data as an example. USP General Chapter <1225> Validation of Compendial Procedures, which aligns with ICH Q2, will be described in detail.
The live version of this recording took place on June 2021Upon completion of this course, you will be able to:
- Recognize fundamentals of test procedure development for biologics.
- Describe the importance of demonstrating method performance using appropriate system suitability
- Identify critical considerations when developing system suitability criteria and controls.
- Explain critical aspects of procedure validation and how to demonstrate successful validation.
- Identify USP biologics resources to support characterization, method development and validation of biologics.
Who Should Participate:
- Analytical Scientists
- R&D Managers
- R&D Analysts
- QC Managers
- QC Analysts
- Regulators
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.