2021 - Analytical Method Validation and Transfer

Topic 1: Regulatory Requirements/Guidance on
This course will provide a thorough review of regulatory guidelines on method validation and transfer. Each element required to have a complete and thorough method validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.
Terminology defined: qualification, validation, revalidation and verification
FDA, EMA, ICH requirements and guidance
Validation lifecycle for analytical methods
Topic 2: Analytical Method Pre-Validation – Stage 1
Analytical Target Profile (ATP)
ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
QC instrumentation qualification
Training
Critical assay reagent qualification
Topic 3: Analytical Method Validation Characteristics – Stage 2
Specificity, accuracy, precision, linearity, range
LOD and LOQ
Robustness and stability-indicating
Value of system suitability controls
Topic 4: Test Method Validation Protocol
Elements of a validation protocol
Pre-planning and planning steps
Identification and documentation of assay characteristics needing to be validated
Critical importance of assigning pre-defined acceptance criteria
Topic 5: Test Method Validation Report
Elements of the validation report
Elements of the validation protocol and the associated final validation report
Meeting the pre-defined acceptance criteria
Handling deviations/OOS’s, when (not if) they happen
Topic 6: Regulatory Concerns About Test Method Validations
Validation issues identified during the review of the submitted market dossier
Validation issues identified during regulatory inspections
Test method validation “continuous improvement” – ICH Q10