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E-Learning – Validasi Metode Analitis

Overview

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 morecommon 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.

Materi

1. Regulatory Requirements/Guidance on Analytical Method Validation

• Terminology Defined: Qualification, Validation, Revalidation and Verification
• FDA, EMA, ICH Requirements and Guidance
• Validation Lifecycle for Analytical Methods

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

3. Analytical Method Validation Characteristics – Stage 2

• Specificity, Accuracy, Precision, Linearity, Range
• LOD and LOQ
• Robustness and Stability-indicating
• Value of System Suitability Controls

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 Criteria

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 Happen

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

Form Registrasi Pelatihan / Training

Jika anda berkeinginan untuk mengikuti Pelatihan E-Learning – Validasi Metode Analitis, anda bisa langsung menghubungi salah satu nomor kami di bawah ini:

• (0274) 4291-355 (08:00 – 16:00)
• 0811 2938 847

Anda juga bisa langsung mengisi Formulir pendaftaran di bawah ini: