3-HOUR VIRTUAL SEMINAR ON ANALYTICAL METHOD VALIDATION AND TRANSFER

Learn how to perform QC analytical test method validations and transfers with our comprehensive course. The validity of data generated through analytical methods is crucial in pharmaceutical drug development and marketing. Regulatory authorities such as the FDA, ICH, and USP have recognized this importance and expanded method validation requirements. However, the lack of clear guidance has left the industry struggling to comply with regulations. Our course offers a comprehensive overview of international regulatory requirements and expectations for test method validation, ensuring that you can meet compliance standards and make informed business decisions based on reliable data.

Why You Should Attend:

Gain essential knowledge and tools for planning and executing test method validation packages in NDA, BLA, and MAA market applications with our upcoming session. Our course covers in-process, release, and stability assays commonly used by QC, providing a comprehensive review of regulatory guidelines on method validation and transfer. We discuss each element required for a complete and thorough method validation in detail, ensuring that attendees have a clear understanding of the requirements. In addition, we cover validation protocol requirements, selection of appropriate acceptance criteria, and how to choose suitable statistical calculations for reporting and interpreting data during the webinar session.

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.