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  5. Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

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
 
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