Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019

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Session Recordings	Speakers
Keynote: CDER’s Commitment to Pharmaceutical Quality	Patrizia Cavazzoni Deputy Center Director for Operations CDER
The Importance of Quality in Our Medicines	Michael Kopcha Director Office of Pharmaceutical Quality (OPQ) | CDER
Quality Assessment of BLAs, NDAs, and ANDAs	Lawrence Yu Deputy Director OPQ | CDER
Application Manufacturing Assessment	Mahesh Ramanadham Office of Process and Facilities (OPF) OPQ | CDER
Policy Initiatives for Pharmaceutical Quality	Ashley Boam Director Office of Policy for Pharmaceutical Quality (OPPQ) OPQ | CDER
Panel Questions and Discussion	Lawrence Yu, Mahesh Ramanadham, Ashley Boam
How Does FDA Execute Pre- and Post-approval Inspections?	Rakhi Shah OPF | OPQ | CDER
Small Molecule Case Studies	Allison Aldridge OPF | OPQ | CDER
Integration of Assessment and Inspection for Biological Products	Candace Gomez-Broughton OPF | OPQ | CDER
Panel Questions and Discussion	Rakhi Shah, Allison Aldridge, Candace Gomez-Broughton
FDA’s Quality Assessment and Knowledge Management - KASA	Geoffrey Wu Office of Lifecycle Drug Products (OLDP) OPQ | CDER
Change Management: ICH Q12 and Established Conditions	Bhagwant Rege OLDP | OPQ | CDER
Panel Questions and Discussion	Geoffrey Wu, Bhagwant Rege
Pharmaceutical Quality Surveillance Program	Lucinda (Cindy) Buhse Director Office of Surveillance (OS) OPQ | CDER
Quality-Related Compliance Actions and Trends	Francis Godwin Director Office of Manufacturing Quality (OMQ) Office of Compliance (OC) | CDER
Quality Metrics, Quality Culture, and Data-Driven Decisions	Tara Gooen OPPQ | OPQ | CDER
Panel Questions and Discussion	Cindy Buhse, Tara Gooen, Francis Godwin
Emerging Technology Program	Sau (Larry) Lee Director Office of Testing and Research (OTR) OPQ | CDER
Policy Considerations for Continuous Manufacturing	Rapti Madurawe OPF | OPQ | CDER Tara Gooen OPPQ | OPQ | CDER
Continuous Manufacturing of Drug Product	Arwa El Hagrasy OPF | OPQ | CDER
Case Studies: Continuous Manufacturing of Drug Substance	Vani Mathur Richards OPF | OPQ | CDER
Panel Questions and Discussion	Larry Lee, Rapti Madurawe, Tara Gooen, Arwa El Hagrasy, Vani Mathur Richards
Assessment of the Multi-Attribute Method	Sarah Rogstad OTR | OPQ | CDER
FDA Research Supporting Emerging Technologies with Case Studies	Thomas O’Connor OTR | OPQ | CDER
End-to-end Integrated Continuous Manufacturing	Salvatore Mascia CEO Continuus
Panel Questions and Discussion	Sarah Rogstad, Thomas O’Connor, Salvatore Mascia
Biosimilars and Interchangeables - Regulatory Highlights	Leila Hann Science Policy Analyst Office of Therapeutic Biologics and Biosimilars (OTBB) Office of New Drugs (OND) | CDER
FDA Perspectives on Biosimilar BLA-Manufacturing	Rachel Novak Office of Biotechnology Products (OBP) OPQ | CDER
Data Quality Expectations for Biosimilars with Case Studies	Merry Christie OBP | OPQ | CDER
Panel Questions and Discussion	Leila Hann, Rachel Novak, Merry Christie
The “Deemed to be a License” Provision of the BPCI Act	Janice Weiner Office of Regulatory Policy (ORP) CDER
Quality Considerations for Transition Biological Products	Leslie Rivera Rosado OBP | OPQ | CDER
Panel Questions and Discussion	Janice Weiner, Leslie Rivera Rosado, Susan Kirshner

About

FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency.

In this era of globalization, engaging stakeholders is essential to furthering the overall commitment to pharmaceutical quality. FDA’s goal for this event is to share information and emphasize the critical role quality plays in assuring the safety and efficacy of pharmaceutical products.

We look forward to discussing this commitment to quality with you at this symposium.

Topics Covered

• Manufacturing and the Quality Assessment of Applications
• Quality Beyond Application Approval
• Emerging Technologies in Pharmaceutical Manufacturing and Design
• Happenings in Biologics: Biosimilars and Transition Biological Products

Intended Audience

• Regulatory affairs professionals (innovator and generic or biosimilar)
• Manufacturing professionals (domestic and foreign; drug product and API)
• Foreign regulators
• Healthcare professionals interested in learning more about the FDA’s drug quality functions

FDA RESOURCES

1. Pharmaceutical Quality Resources
2. FDA’s Office of Pharmaceutical Quality
3. Facts About the Current Good Manufacturing Practices (CGMPs)
4. Report on the State of Pharmaceutical Quality, 2018