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.
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.
1. Regulatory requirements and guidance
2. Pre-validation (stage 1)
3. Validation characteristics (stage 2)
4. Test method validation protocol
5. Test method validation report
6. Regulatory concerns
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.
1. Regulatory requirements and guidance
2. Pre-validation (stage 1)
3. Validation characteristics (stage 2)
4. Test method validation protocol
5. Test method validation report
6. Regulatory concerns
Kelly Thomas
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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