SBIA Education Events

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

Pharmaceutical Quality Symposium 2016 – Files Page

Click to Download the Agenda

July 20:

Keynote
Michael Kopcha, PhD, RPh
Click for Recording
Introduction to the Office of Process and Facilities (OPF)
Robert Iser, MS
Click for Recording
Current Thinking on Microbiological Controls for Nonsterile Drug Products
Erika A. Pfeiler, PhD
Click for Recording
Aseptic Processing of Biological Products: Current Regulatory Issues
Candace Gomez-Broughton, PhD
Click for Recording
Microbiological Assessment Considerations Panel Click for Recording
Recommendations for Manufacturing Process Information in Prescription Drug Applications
Akm Khairuzzaman, PhD
Click for Recording
Manufacturing Process: Common Deficiencies and Recommendations for Information Request Responses
Ubrani Venkataram, PhD
Click for Recording
Manufacturing Process Considerations for Immediate & Modified Release Products
Rakhi B. Shah, MS, PhD
Click for Recording
Manufacturing Process Considerations for Lyophilized Products
Kumar Janoria, PhD
Click for Recording
Manufacturing Process Assessment Considerations Panel Click for Recording
Current Submissions Expectations for Facility Information
Quallyna Porte, MBA
Click for Recording
Lifecycle Facility Assessment
Christina Capacci-Daniel, PhD
Click for Recording
Facility Assessment Considerations Panel Click for Recording

July 21:

Points to Consider for the CMC Review of Therapeutic Biologics
Willie Wilson III, PhD
Click for Recording
Analytical Procedures and Method Validation
Lucinda (Cindy) Buhse, PhD
Click for Recording
Hot Topics – Drug Substance Review in CDER
M. Scott Furness, PhD
Click for Recording
Emerging Technology/CM
Sau (Larry) Lee, PhD
Click for Recording
Panel Discussion Click for Recording
Complex Drug Substances
Kshitij A. Patkar, PhD
Click for Recording
Risk-Based CMC Review/Quality Informatics in Knowledge Management
Andre Raw, PhD
Click for Recording
Application of process capability in pharmaceutical manufacturing
Alex Viehmann
Click for Recording
Panel Discussion Click for Recording
Post-Approval Change Management with sANDA Examples and Case Studies
Niles Ron, PhD, MBA
Click for Recording
Biopharmaceutics Review – Current Practices and Expectations
Tapash Ghosh, PhD
Click for Recording
Practical Implementation of ICH Q3D: Guideline on Elemental Impurities
John Kauffman, PhD
Click for Recording
Proper CMC Submission-ANDA and Content of CMC Section
Nashed Samaan, PhD
Click for Recording
Panel Discussion Click for Recording