Pharmaceutical decisions depend on analytical methods that produce valid data on a product's safety, identity, strength, purity and quality. This 90-minute analytical method validation and transfer course reviews the regulatory guidance and shows how to validate and transfer QC test methods.

FDA, ICH and USP have all expanded validation requirements, yet guidance on how to comply is limited. You'll cover terminology, the validation lifecycle, pre-validation work such as the analytical target profile, and each validation characteristic, from specificity and accuracy to LOD, LOQ and robustness.

The course also covers protocols, acceptance criteria, statistics, reports and deviations, with a focus on efficient experimental design and documentation.

WHY SHOULD YOU ATTEND?

Validation shows that a method is fit for its intended use, and regulators require the data for NDA, BLA and MAA submissions covering in-process, release and stability assays. This course gives you the knowledge and tools to plan and execute validation packages and avoid the issues reviewers and inspectors commonly find.

It suits analytical development, QA, QC, validation and regulatory affairs professionals involved in method development, validation, verification or transfer.

AREA COVERED

1. Regulatory requirements and guidance

• Review of regulatory guidelines on method validation and transfer
• Terminology: qualification, validation, revalidation and verification
• FDA, EMA and ICH requirements and guidance
• The validation lifecycle for analytical methods

2. Pre-validation (stage 1)

• Analytical target profile (ATP)
• ICH Q8, Q9 and Q10 pre-validation requirements
• QC instrument qualification
• Training
• Critical assay reagent qualification

3. Validation characteristics (stage 2)

• Specificity, accuracy, precision, linearity and range
• LOD and LOQ
• Robustness and stability-indicating methods
• The value of system suitability controls

4. Test method validation protocol

• Elements of a validation protocol
• Pre-planning and planning steps
• Identifying and documenting the assay characteristics to validate
• Why acceptance criteria must be set in advance

5. Test method validation report

• Elements of the validation report and how it links to the protocol
• Meeting the pre-defined acceptance criteria
• Handling deviations and OOS results when they happen

6. Regulatory concerns

• Validation issues found during market dossier review
• Validation issues found during inspections
• Continuous improvement of test method validation under ICH Q10

LEARNING OBJECTIVES

• Define qualification, validation, revalidation and verification
• Apply FDA, EMA and ICH guidance across the analytical method validation lifecycle
• Complete pre-validation steps, including the analytical target profile and instrument qualification
• Evaluate specificity, accuracy, precision, linearity, range, LOD, LOQ and robustness
• Write validation protocols with pre-defined acceptance criteria and suitable statistics
• Prepare validation reports and handle deviations and OOS results
• Anticipate validation issues raised in dossier reviews and inspections

WHO WILL BENEFIT?

• Analytical Development
• Quality Assurance
• Quality Control
• Validation
• Regulatory Affairs