Overview: The ICH guideline on Validation of Analytical Procedures (Q2R1) delineates the guidance and methodology for validation characteristics of an analytical procedure.
Like most guidelines, the terminology is vague enough to allow for several acceptable approaches and analysis. Appropriate statistical methods should be used and all relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate. A statistical approach to validation of analytical methods can minimise the amount of testing while meeting the requirements of the guideline.
Areas Covered in the Session: Introduction to ICH Q2R1 Statistical methods used during validation Accuracy versus Precision Examples and case studies Who Will Benefit: Anyone responsible for, or affected by, FDA regulations on analytical method validation Management Research and Development Regulatory Affairs personnel Quality assurance/quality control personnel Auditors and inspectors
Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specialising in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics. Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.
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