Analytical Method Validation and Transfer Course
Learn to plan and run QC analytical method validations and transfers that meet FDA, EMA and ICH expectations, from pre-validation and protocols to reports and deviations.
Speaker
Kelly Thomas
cGMP quality and validation consultant · 20+ years in cGMP industry
Overview
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 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.
What’s covered
- 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
- Analytical target profile (ATP)
- ICH Q8, Q9 and Q10 pre-validation requirements
- QC instrument qualification
- Training
- Critical assay reagent qualification
- Specificity, accuracy, precision, linearity and range
- LOD and LOQ
- Robustness and stability-indicating methods
- The value of system suitability controls
- 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
- 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
- Validation issues found during market dossier review
- Validation issues found during inspections
- Continuous improvement of test method validation under ICH Q10
Who should attend
What you get
About the speaker
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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