Ensuring Data Integrity in Method Validations 2018

Topics

• Going through Validation Parameters, Tests, and Acceptance Criteria
• Scope and Content of the Guidance
• Lifecycle Management of Analytical Procedures, Including Periodic Review and Revalidation
• Performing Pre-Validation Studies
• Analytical Method Transfer Studies
• Analytical Method Equivalency Studies to Alternative Analytical Procedures (i.e. USP methods)
• Data Integrity and Documentation Requirements

Who should Attend

• Laboratory Managers and Staff
• Contract Laboratory Staff
• QA Managers and Personnel
• Analysts
• Training Department Personnel
• Regulatory Affairs Personnel
• Validation Specialists
• Documentation Department Personnel