Analytical Method Validation and Transfer

This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.

Why Should You Attend:

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.

Areas Covered in the Webinar:

• • 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

Who Will Benefit:

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