Validation of Analytical Methods and Procedures

Overview:

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.

Reference Material for Easy Implementation

• SOP: Transfer of Analytical Methods
• Checklist: Transfer of Analytical Methods and Procedures
• Master Plan Template and Examples: Transfer of Analytical Methods and Procedures

Areas Covered in the Session:

• Current and new guidelines from FDA, WHO, EMA and USP
• Examples of warning letters and how to avoid them
• Developing an SOP for method validation
• Development of a validation plan for success
• Prerequisites for method validation
• Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
• Defining test conditions and acceptance limits
• Verification of compendial methods according to USP <1226>
• To revalidate or not after method changes
• Ensuring on-going method performance through periodic review
• Transferring a method to routine according to USP <1224>
• Seven most common method validation pitfalls and how to avoid them
• Documentation for the FDA and for other agencies

Who Will Benefit:

• Laboratory Managers and Supervisors
• GLP/GCP/GMP Auditors
• ISO 17025 Auditors
• QA/QC Managers and Personnel
• Analysts and Other Laboratory Staff
• Regulatory Affairs
• Training Departments
• Consultants