Section A

9:00-10:30

Introduction

• Executive Overview of CTD Quality Submissions
• Writing CTD submission-ready reports
• CTD Agency Review
• Benefits of CTD
• Tips for preparing submissions
• The eCTD

10:30-11:00

Section B

11:00-12:30

DS Characterization and Manufacture

• General Information
• Structure
• Impurities
• Manufacturing Process Description
• Manufacturing Process Development/Validation
• Critical Steps
• Equivalence/Comparability

12:30-1:30

Section C

1:30-3:30

DP Manufacture

• Pharmaceutical Development
• Manufacturing Process Description
• Manufacturing Process Development/Validation
• Container-Closure

FDA Draft Guidance

Regional Guidelines

3:00-3:30

Section D

3:30-5:00

Q&A, Review of Templates

Section E

9:00-10:30

Analytical - DS and DP

• Specifications
• Analytical Methods
• Method Validation Reports
• Control of Excipients
• Batch Analyses
• Drug Product Characterization
• Justification of Specifications

10:30-11:00

Section F

11:00-12:30

Stability - DS and DP

• Format of CTD sections
• Presenting Stability Data
• Statistical Section, Extrapolations
• Stress Study Data
• Stability Strategies

12:30-1:30

Section G

1:30-3:00

Appendices/Regional

• Facilities and Equipment
• Adventitious Agents
• Novel Excipients
• Regional Requirements

Post-Approval Changes

3:00-3:30

Section H

3:30-5:00

Case Studies

Review of company documents