SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

REdI Fall Conference 2016 – Files

Event Evaluation & Certificate of Attendance

View the Agenda

The session recordings will be available shortly after each day concludes.

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
Slides in ZIP file above
Recording
Resources
Diane Nell,
Slides in ZIP file above
Recording
Design Controls
Stanley Liu
Slides in ZIP file above
Recording
Device Clinical Trials/IDE Program
Soma Kalb
Slides in ZIP file above
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
Slides in ZIP file above
Recording
Application of cGMPs to Drug Product Quality Microbiology Laboratory Tests and Manufacturing Process Validation
John Metcalfe
Slides in ZIP file above
Recording
BA/BE Inspections and Surveillance
Arindam Dasgupta
Slides in ZIP file above
Recording
ACE/ITDS: FDA Implementation Update and Tips for Drug Importers
Jean E. McCue
Slides in ZIP file above
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
Slides in ZIP file above
Recording

September 28:

Device Track:

Welcome and Overview of Day 2
Joseph Tartal
Slides in ZIP file above
Recording
Quality System Overview
Aileen Velez Cabassa
Slides in ZIP file above
Recording
Management Controls
Tonya Wilbon
Slides in ZIP file above
Recording
Basics of Risk Management for Quality Systems
Joseph Tartal
Slides in ZIP file above
Recording
Complaints
Anike Freeman
Slides in ZIP file above
Recording
FDA Medical Device Inspections
Marc Neubauer
Slides in ZIP file above
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
Slides in ZIP file above
Recording
Ensuring Quality over the Product Lifecycle: Risk-based Product Specific Inspections in OPQ
Derek Smith
Slides in ZIP file above
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
Slides in ZIP file above
Recording
Best Practices for Communication Between IND Sponsors and FDA during Drug Development
Rachel Hartford
Slides in ZIP file above
Recording