Analytical Test Methods Validation for GxP Laboratory Compliance: FDA, ICH and USP Requirements

Overview:

This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.

As products are developed from R&D through pre-clinical, clinical and commercial phases, the requirements for analytical test method validation also evolve to meet the increasing regulatory requirements. It is important to know when to do what - too much or unnecessary validation is costly and can delay development programs, while insufficient validation can mean rejection of an application.

This seminar will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation. We will cover the FDA, ICH and USP requirements, and illustrate the components of validation and ways to expedite the validation process. We will cover both small molecule test methods and biotechnology assays, and suggested parameters to validate in each case. The documentation associated with test method validation will be reviewed.

Areas Covered in the Session:

• Regulatory requirements for test method validation
• Phase-appropriate test method validation
• Elements of test method validation
• FDA, ICH and USP requirements for validation
• Documenting test method validation

The employees who will benefit include:

• End-users responsible for testing
  
• QA Managers and Validation Personnel
  
• Analytical Development Managers and Personnel
  
• Senior Quality, Facilities and R&D Management
  
• Quality Control Staff
  
• Quality System Auditors