This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this relative to the drug development process and have each expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC.
Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include some of the more common mathematical and statistical treatments of validation data. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions.
Agenda
Topic 1: Regulatory Requirements/Guidance on Analytical MethodValidation- Terminology defined: qualification, validation, revalidation and verification
- FDA, EMA, ICH requirements and guidance
- Validation lifecycle for analytical methodsTopic 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 qualificationTopic 3: Analytical Method Validation Characteristics - Stage 2
- Specificity, accuracy, precision, linearity, range
- LOD and LOQ
- Robustness and stability-indicating
- Value of system suitability controlsTopic 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 criteriaTopic 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 happenTopic 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
Who Should Attend
- Personnel from the pharmaceutical and medical device industry
- Manufacturers of drug substances (APIs)
- Contract laboratory staff
- Laboratory managers and staff
- Analysts
- QA managers and personnel
- Regulatory affairs personnel
- Training department personnel
- Documentation department personnel
- Consultants
- Validation specialists
