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 |
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 |