Course Description:
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the key aspects of the seminar include:
Learning how to apply QbD concepts to analytical methods
Discussing the types of methods required for different drug products
Understanding the types of impurities which must be addressed for drug products
Discovering how a lifecycle approach can link method development, validation, verification and transfer
Learning how ATP (Analytical Target Profile) can drive the lifecycle approach
Determining the importance of linking method uncertainty to specifications
Using a method feedback loop to facilitate method improvement
This approach will be linked with current compendial requirements. There will be opportunities for questions and interaction throughout the course as well.
Learning Objectives:
Understand the lifecycle approach to method development and validation
Understand the different methods required for various drug products and the types of impurities which must be addressed
Identify an ATP for methods being developed
Use an IQ/OQ/PQ approach to method qualification
Develop appropriate protocols for method transfer
Comply with compendial requirements with greater success and fewer resources
Who Will Benefit:
This seminar on QbD concepts in method development will prove highly beneficial to professionals working in pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods.
Chemists (Research, Quality Control, CRO)
Regulatory Affairs/CMC Personnel
Laboratory Managers and Staff
Analysts
QA/QC Managers and Personnel
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the key aspects of the seminar include:
Learning how to apply QbD concepts to analytical methods
Discussing the types of methods required for different drug products
Understanding the types of impurities which must be addressed for drug products
Discovering how a lifecycle approach can link method development, validation, verification and transfer
Learning how ATP (Analytical Target Profile) can drive the lifecycle approach
Determining the importance of linking method uncertainty to specifications
Using a method feedback loop to facilitate method improvement
This approach will be linked with current compendial requirements. There will be opportunities for questions and interaction throughout the course as well.
Learning Objectives:
Understand the lifecycle approach to method development and validation
Understand the different methods required for various drug products and the types of impurities which must be addressed
Identify an ATP for methods being developed
Use an IQ/OQ/PQ approach to method qualification
Develop appropriate protocols for method transfer
Comply with compendial requirements with greater success and fewer resources
Who Will Benefit:
This seminar on QbD concepts in method development will prove highly beneficial to professionals working in pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods.
Chemists (Research, Quality Control, CRO)
Regulatory Affairs/CMC Personnel
Laboratory Managers and Staff
Analysts
QA/QC Managers and Personnel
