Analytical Method Validation and Transfer 2019 is a webinar that covers topics such as:
- Analytical Method Pre-Validation - Stage 1
- ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
- Analytical Target Profile (ATP)
- Regulatory Requirements/Guidance on Analytical Method Validation
- FDA, EMA, ICH requirements and guidance
- Terminology defined: qualification, validation, revalidation and verification
- Test Method Validation Protocol
- Pre-planning and planning steps
- Elements of a validation protocol
- Analytical Method Validation Characteristics - Stage 2
- LOD and LOQ
- Specificity, accuracy, precision, linearity, range
- Test Method Validation Report
- Elements of the validation protocol and the associated final validation report
- Elements of the validation report
Analytical Method Validation and Transfer 2019 is intended for:
- Quality Control Departments
- Quality Assurance Departments
- Validation Departments
- Regulatory Affairs Departments
- Analytical Development Teams
