Analytical Test Methods Validation: FDA, ICH and USP Requirements

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.

Why Should You Attend:

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.

Areas Covered in the seminar:

• 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.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and manufacturing services will also benefit.

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