Dec. 7, 2017
 

9 a.m. 
 

Registration and Continental Breakfast
 

10 a.m. 
 

Introduction
 

10:30 a.m.
 

Session 1: Qualifications and Resources
• Case studies and special circumstances
• Performing our work with consideration of ASOPs

 

12:45 p.m. 
 

Lunch
 

1:45 p.m.
 

Session 2: Regulatory Perspective
 

3:15 p.m.
 

Session 3: Assessing and Communicating the Risk of Material Adverse Deviation
 

4:30 p.m.
 

Break
 

5 p.m.
 

Session 4: Workshop on Crafting Opinions 6:30 p.m. Adjourn
 


Dec. 8, 2017
 

7 a.m.
 

Continental Breakfast
 

8 a.m.
 

Day 1 Recap & Day 2 Introduction
 

8:15 a.m. 
 

Session 5: Documentation
• Overview of the 2016 Practice Note
• Data, documentation, and report writing

 

10:30 a.m.
 

Break
 

10:45 a.m. 
 

Session 6: Common Approaches to Developing and Communicating a Range
 

11:45 a.m.
 

Panel and Q&A with all presenters
 

12:30 p.m.
 

Lunch
 

1 p.m.
 

Optional Tutorial: Small Group Q&A
• An opportunity for attendees to go over topics and issues with presenters.

 

2 p.m.
 

Adjourn


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