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July 20:
| Keynote Michael Kopcha, PhD, RPh |
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| Introduction to the Office of Process and Facilities (OPF) Robert Iser, MS |
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| Current Thinking on Microbiological Controls for Nonsterile Drug Products Erika A. Pfeiler, PhD |
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| Aseptic Processing of Biological Products: Current Regulatory Issues Candace Gomez-Broughton, PhD |
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| Microbiological Assessment Considerations Panel | Click for Recording |
| Recommendations for Manufacturing Process Information in Prescription Drug Applications Akm Khairuzzaman, PhD |
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| Manufacturing Process: Common Deficiencies and Recommendations for Information Request Responses Ubrani Venkataram, PhD |
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| Manufacturing Process Considerations for Immediate & Modified Release Products Rakhi B. Shah, MS, PhD |
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| Manufacturing Process Considerations for Lyophilized Products Kumar Janoria, PhD |
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| Manufacturing Process Assessment Considerations Panel | Click for Recording |
| Current Submissions Expectations for Facility Information Quallyna Porte, MBA |
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| Lifecycle Facility Assessment Christina Capacci-Daniel, PhD |
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| Facility Assessment Considerations Panel | Click for Recording |
July 21:
| Points to Consider for the CMC Review of Therapeutic Biologics Willie Wilson III, PhD |
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| Analytical Procedures and Method Validation Lucinda (Cindy) Buhse, PhD |
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| Hot Topics – Drug Substance Review in CDER M. Scott Furness, PhD |
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| Emerging Technology/CM Sau (Larry) Lee, PhD |
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| Panel Discussion | Click for Recording |
| Complex Drug Substances Kshitij A. Patkar, PhD |
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| Risk-Based CMC Review/Quality Informatics in Knowledge Management Andre Raw, PhD |
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| Application of process capability in pharmaceutical manufacturing Alex Viehmann |
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| Panel Discussion | Click for Recording |
| Post-Approval Change Management with sANDA Examples and Case Studies Niles Ron, PhD, MBA |
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| Biopharmaceutics Review – Current Practices and Expectations Tapash Ghosh, PhD |
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| Practical Implementation of ICH Q3D: Guideline on Elemental Impurities John Kauffman, PhD |
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| Proper CMC Submission-ANDA and Content of CMC Section Nashed Samaan, PhD |
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| Panel Discussion | Click for Recording |