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Session 8 Track 4: Submission Quality
Session Chair(s)
Daniel Offringa
Principal Consultant, eSub Solutions, United States
This session covers submission quality both from an Industry and FDA perspective. Beginning at the document level, we will outline how organizations can streamline their Word and PDF content preparation processes. We will also cover common administrative and technical errors in regulatory submissions and how to avoid [and/or solve] them. Finally, an overview of FDA’s regulatory submission processing will be provided, along with suggestions for Industry on how to optimize submissions.
Learning Objective : At the conclusion of this session, participants should be able to:
- Assess their current content preparation processes and implement improvements in efficiency and quality
- Recognize common electronic submission errors and identify tools and techniques to avoid and/or solve them
- Describe FDA’s submission processing and identify practices that can be implemented to minimize potential issues
Speaker(s)
Geert Van Peteghem, MBA
Product Line Leader, DocShifter, Belgium
How Automated Checking & Fixing of Word & PDF Content Accelerates Achieving Submission Compliance
Rachel Bombara
Sr. Regulatory Services Manager, Certara, United States
Oops, I Made a Mistake! Common Mistakes, Errors and Omissions- How to Avoid Them & What to do if You Make One
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management , FDA CDER, United States
An Overview of FDA Submission Processing
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