Analytical method development, optimization and validation

WHO SHOULD ATTEND?

This course is intended for individuals who have the responsibility for establishing and measuring the integrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosage forms.

This course will benefit individuals in:

• R&D
• Quality Control
• Quality Assurance
• Regulatory affairs personnel responsible for the review of such data will also benefit from this course.

Course Topics:

• Introduction
• HPLC methods
• Functional group analysis
• Sample information scouting
• Define your goals
• Column selection
• Column specifications
• Mobile phase selection
• Detector selection
• Method optimization
• Pre-validation
• Analytical method validation
• Transfer of analytical procedures
• Analytical method verification
• Conclusion
• References

Instructors:

Dr. Ahmed Ma’mun