09:00 AM - 02:00 PM
Day 1

SESSION 1:
- Seminar objectives review, expectations and scope.
- Drug Approval Process and Regulatory (FDA) Requirements (private standards)
- Pharmacopeias and Compendial (USP) Approval Process (public standards)

SESSION 2:
- Compendial Harmonization Process
- Chromatography System Suitability Requirements
- Allowed Adjustments of Chromatographic System Parameters

SESSION 3:
- Analytical Instrument Qualifications
- Instrument Categories
- Qualification Phases (DQ, IQ, OQ, PQ)

SESSION 4:
- Analytical Method Validation (typical validation parameters)
- Specificity
- Precision/Accuracy
- Linearity/Range
- LOD and LOQ

09:00 AM - 02:00 PM
Day 2

SESSION 5:
- Analytical Method Verification
- FDA and USP Requirements
- Factors to Consider

SESSION 6:
- Analytical Method Transfer
- Different Approaches

SESSION 7:
- Analytical Procedure Life Cycle

SESSION 8:
- Setting Specifications FDA regulations and ICH guidelines (Q6A)
- Out-of-Specification (OOS)
- Out of Trend (OOT)
- How to handle OOS and OOT?

SESSION 9:
- Summary, Review and Q&A Session