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. 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 prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.

Reference material for easy implementation:

• SOP: Validation of Analytical Methods
  
• Checklist: Validation of Analytical Methods
  
• 65-page Primer: Validation of Analytical Methods

Areas Covered in the Session:

• FDA regulations and guidelines
  
• Examples of warning letters and how to avoid them
  
• USP Chapters and ICH Guides
  
• 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
• Transferring a method to routine according to USP <1224>
  
• Seven most common method validation pitfalls and how to avoid them
  
• Using software for automated method validation
  
• 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