9:00 am – 10:00 am

Characterization and Impurities Considerations

10:00 am – 10:30 am

Control of DS

10:30 am – 10:45 am

 Break

10:45 am – 11:45 am

Analytical Method Validation, Reference Standards and Stability

11:45 am – 12:00 pm

Breakout Session #2

12:00 pm – 1:00 pm

Lunch

1:00 pm – 1:15 pm

Breakout Session #2 – Teams Feedback

1:15 pm – 1:45 pm

Drug Product Considerations

1:45 pm – 2:15 pm

Appendices (Facilities and Equipment, Adventitious Agents)

2:15 pm – 2:30 pm

Break

2:30 pm – 3:30 pm

Comparability

3:30 pm – 4:00 pm

Question and Answer