Gain an understanding of a lifecycle approach to developing and validating analytical methods for drug products. The webinar will focus on analytical target profile too for improving the design and evaluation of HPLC methods.
Once the specificity requirements are understood, a technique that starts with gradient elution to understand the ‘chromatography space’ moves to focused conditions and explores ‘method understanding. It will effectively help prepare for method validation and subsequent method transfer. Attendees will also have the opportunity to be a part of a Q&A discussion with the presenter at the end of the session.
Upon completion of the course, attendees will be able to:
Why Should You Attend:
This webinar is designed to offer an efficient, lifecycle approach to develop analytical methods for drug products. Starting by identifying the analytical target profile, several discrete steps will be explored which will lead to method validation designed to meet the needs of the developer.Once the specificity requirements are understood, a technique that starts with gradient elution to understand the ‘chromatography space’ moves to focused conditions and explores ‘method understanding. It will effectively help prepare for method validation and subsequent method transfer. Attendees will also have the opportunity to be a part of a Q&A discussion with the presenter at the end of the session.
Upon completion of the course, attendees will be able to:
- Identify the various stages in the lifecycle of an analytical method and be aware of strategies to address the requirements for each stage.
- Apply the concept of analytical target profile for improving the design and evaluation of analytical methods.
- Gather the information necessary for successful method development, and use a ‘gradient-first’ approach to accelerate identification of suitable chromatographic conditions.
- Develop an understanding of analytical method performance to avoid common pitfalls.
- Prepare for successful method validation, demonstrating that the method is suitable for its intended use.
Areas Covered in the Webinar:
- Overview of a lifecycle approach to develop and validate analytical methods.
- Identifying the analytical target profile: what is the intended use of the method, and what desired characteristics (analytical technique, time constraints, solvent limitations, etc.) have been identified.
- Information gathering: what is known (or needs to be known) about the compound and the drug product?
- Using gradient elution HPLC to characterize the ‘chromatographic space’.
- Polishing the chromatography: pulling together the specificity requirements and the chromatographic characteristics.
- Developing understanding about the method and searching for weaknesses.
- Systematic evaluation of method parameters: robustness and intermediate precision.
- Preparing for validation and for method transfer.
Who Will Benefit:
- Chemists
- Managers responsible for development or validation of analytical methods
- Quality assurance personnel responsible for laboratory and analytical methods
- Regulatory affairs/CMC personnel responsible for filings involving analytical methods
Course Provider
Gregory Martin,
