Analytical Method Validation and Transfer

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, the 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.

Why You Should Attend:

Join this session to gain 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.

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. A review of validation protocol requirements and selection of appropriate acceptance criteria will also occur during the webinar session; as well as, a discussion on how to select suitable statistical calculations for reporting and interpreting the data.

Areas Covered in the Session :

Regulatory Requirements/Guidance on Analytical Method Validation

• Terminology defined: qualification, validation, revalidation and verification
• FDA, EMA, ICH requirements and guidance

Analytical Method Pre-Validation – Stage 1

• Analytical Target Profile (ATP)
• ICH Q8, Q9 and Q10 adherence – Pre-Validation Requirements

Analytical Method Validation Characteristics – Stage 2

• Specificity, accuracy, precision, linearity, range
• LOD and LOQ

Test Method Validation Protocol

• Elements of a validation protocol
• Pre-planning and planning steps

Test Method Validation Report

• Elements of the validation report
• Elements of the validation protocol and the associated final validation report

Who Should Attend:

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

Course Director: 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.