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September 27:

PLENARY: FDA Insights on Products for Rare Diseases and Pediatrics
Eric Chen, MS; Jonathan Goldsmith, MD; Vasum Peiris, MD
Slides in ZIP file above
Recording

Device Track:

Overview of CDRH and Basic Submission Process
Elias Mallis
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Recording
Resources
Diane Nell,
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Recording
Design Controls
Stanley Liu
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Recording
Device Clinical Trials/IDE Program
Soma Kalb
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Recording
501(k) Program
Kimberly Piermatteo
Slides in ZIP file above
Recording
de novo Program
Sergio de del Castillo
(No slides for this session)
Recording
PMA Program
Donna Headlee
Slides in ZIP file above
Recording
Wrap Up Q&A
All the Day’s Speakers
(No slides for this session)
Recording

Drug Track:

Emerging Technology Team: FDA’s Tool to Facilitate and Promote Pharmaceutical Innovation
Mohan Sapru
Slides in ZIP file above
Recording
Prescribing Information: Resources, Review Process, and Guidances Under Development
Eric Brodsky
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Recording
Application of cGMPs to Drug Product Quality Microbiology Laboratory Tests and Manufacturing Process Validation
John Metcalfe
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Recording
BA/BE Inspections and Surveillance
Arindam Dasgupta
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Recording
ACE/ITDS: FDA Implementation Update and Tips for Drug Importers
Jean E. McCue
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Recording
The Drug Supply Chain Security Act (DSCSA): Implementation Updates
Connie T. Jung
Slides in ZIP file above
Recording
Beyond Guidance: Formal Meetings and Requests for Information
Kevin Bugin
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Recording

September 28:

Device Track:

Welcome and Overview of Day 2
Joseph Tartal
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Recording
Quality System Overview
Aileen Velez Cabassa
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Recording
Management Controls
Tonya Wilbon
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Recording
Basics of Risk Management for Quality Systems
Joseph Tartal
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Recording
Complaints
Anike Freeman
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Recording
FDA Medical Device Inspections
Marc Neubauer
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Recording
Wrap Up and Q&A
All the Day’s Speakers
(No slides for this session)
Recording

Drug Track:

Welcome and Introducing the New SBIA Webpages
Brenda Stodart
(No slides for this session)
Recording
Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER
Suranjan De & Kimberly Swank
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Recording
Ensuring Quality over the Product Lifecycle: Risk-based Product Specific Inspections in OPQ
Derek Smith
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Recording
Increasing the Quality and Efficiency of Clinical Trials: The Clinical Trials Transformation Initiative (CTTI)
Kristen Miller
Slides in ZIP file above
Recording
Risk and Team-based Integrated Quality Assessment in the Office of Pharmaceutical Quality
M. Scott Furness
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Recording
Best Practices for Communication Between IND Sponsors and FDA during Drug Development
Rachel Hartford
Slides in ZIP file above
Recording