Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices 2018

Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices 2018 is an event dedicated to learn how to develop compliant validation protocol and analytical procedures as per FDA and USP guidance.

Topics

• Familiarize with FDA requirements of analytical procedures
• Discuss GMP regulatory requirements for Analytical Test Methods
• Understand USP Good Documentation Practices
• Development of method validation protocols
• Establish acceptance criteria for validation
• Discuss lifecycle management of method validation

Who should Attend

• QA and QC Managers
• R&D Analysts
• Directors
• Regulatory Scientists
• Manufacturers
• Regulators
• Quality Managers and Personnel
• Laboratory Managers
• Regulatory Affairs