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Symposium | Virtual

Event Title
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World
October 26 - 27, 2021

Scheduled

Date:
October 26 - 27, 2021
Day1:
- ET
Day2:
- ET

 

Topics & Presentations

Speakers

Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses

Regulation of Pharmaceutical Quality in the U.S.

Policy Updates on Pharmaceutical Quality

FDA’s Facility Oversight

Panel Questions and Discussion

Janet Woodcock
Acting Commissioner of Food and Drugs
Food and Drug Administration

Michael Kopcha
Director
Office of Pharmaceutical Quality (OPQ) | CDER

Lucinda Buhse
Deputy Director for Operations
OPQ | CDER

Laurie Graham
Director
Division of Internal Policies and Programs (DIPAP)
Office of Policy for Pharmaceutical Quality (OPPQ)
OPQ | CDER

Stelios Tsinontides
Director
Office of Pharmaceutical Manufacturing Assessment (OPMA)
OPQ | CDER

Nancy Rolli
Deputy Director
Office of Pharmaceutical Quality Operations (OPQO)
Office of Regulatory Affairs (ORA)

Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion

Ashley Boam
Director
OPPQ | OPQ | CDER

Michael Kopcha
Director
OPQ | CDER

Theresa Mullin
Associate Director for Strategy
Office of the Center Director (OCD) | CDER

Don Ashley
Director
Office of Compliance (OC) | CDER

Elizabeth Miller
Assistant Commissioner
Office of Medical Products and Tobacco Operations (OMPTO)
ORA

 

Pharmaceutical Quality Symposium 2021 Part 3

Integrated Quality Assessment (IQA): Aligned Teams

Knowledge-Aided Assessment and Structured Application (KASA): Part 1

Knowledge-Aided Assessment and Structured Application (KASA): Part 2

Quality Surveillance Dashboard (QSD)

Panel Questions and Discussion

Don Henry
Director
Office of Program and Regulatory Operations (OPRO)
OPQ | CDER

Ee-Sunn “Joanne” Chia
Division Director
Division of New Drug Products III (DNDP III)
Office of New Drugs Products (ONDP)
OPQ | CDER

Joel Welch
Associate Director for Science
Office of Biotechnology Products (OBP)
OPQ | CDER

Alex Viehmann
Division Director
Division of Quality Intelligence II
Office of Quality Surveillance (OQS)
Office of Pharmaceutical Quality (OPQ) | CDER

Pharmaceutical Quality Symposium 2021 Part 4

The Importance of International Harmonization

Quality-Related Compliance Updates and Innovations

Quality Management Maturity (QMM)

Panel Questions and Discussion

Brian Hasselbalch
Deputy Director
OPPQ | OPQ | CDER

Francis Godwin
Office Director
Office of Manufacturing Quality (OMQ)
OC | CDER

Jennifer Maguire
Director
OQS |OPQ | CDER

Pharmaceutical Quality Symposium 2021 Part 5

Control of Nitrosamine Impurities in Human Drugs

Research Fueling Approvals: A Case Study of Glucagon

Research Fueling Approvals: A Case Study of Enteral Feeding Tubes

Research Fueling Approvals: A Case Study of Ferumoxytol

Panel Questions and Discussion

Jason Rodriguez
Division Director
Division of Complex Drug Analysis
Office of Testing and Research (OTR)
OPQ | CDER

Ilan Geerlof-Vidavsky
Chemist
Division of Pharmaceutical Analysis (DPA)
OTR | OPQ | CDER

Cameron Smith
Supervisory Chemist
Division of Liquid-Based Products (DLBP)
Office of Lifecycle Drug Products (OLDP)
OPQ | CDER

Alicia Hoover
Chemist
DPA | OTR | OPQ | CDER

Namrata Trivedi
Chemist
Division of Immediate and Modified Release
Products III (DIMRPIII)
OLDP | OPQ | CDER

Charudharshini Srinivasan
Research Scientist, Staff Fellow
Division of Product Quality Research (DPQR)
OTR | OPQ | CDER

Yiwei Li
Supervisory Chemist
Division of Pharmaceutical Manufacturing Assessment
III (DPMAIV)
OMPA | OPQ | CDER

Pharmaceutical Quality Symposium 2021 Part 6

Keeping Products Safe for Consumers

The State of Pharmaceutical Quality

Panel Questions and Discussion

 

Connie Ruzicka
Lab Chief
DPA | OTR | OPQ | CDER

Neil Stiber
Associate Director for Science and Communication
OQS | OPQ | CDER

Pharmaceutical Quality Symposium 2021 Part 7

Emerging Technology Program 2.0

Addressing the Advanced Manufacturing Regulatory Framework

Panel Questions and Discussion

 

Sau “Larry” Lee
Deputy Director of Science
OPQ | CDER

Adam Fisher
Acting Associate Director of Science and Outreach
OPQ | CDER

Pharmaceutical Quality Symposium 2021 Part 8 with Closing Remarks

FDA's Advanced Manufacturing Product Development Science Program

Extramural Advanced Manufacturing Product Development Science: Continuus

Industry Development of Advanced Manufacturing: On Demand Pharmaceuticals

Panel Questions and Discussion

Closing Words from the Office of Pharmaceutical Quality

Thomas O’Connor
Division Director
Division of Product Quality Research
OTR | OPQ | CDER

Ernie Penachio
Vice President of Technical Operations
Continuus Pharmaceuticals

John Lewin
Chief Medical Officer
On Demand Pharmaceuticals, Inc.

Michael Kopcha
Director
OPQ | CDER

Janet Woodcock, M.D.
Janet Woodcock M.D.

KEYNOTE SPEAKER

Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration


Slides

Agenda

Visit CDER Small Business and Industry Assistance Webpage


ABOUT THIS SYMPOSIUM
Please join us at this symposium, in a commitment to quality for the benefit of patients and consumers. A part of the SBIA Regulatory Education for Industry (REdI) series, the symposium will address the latest developments in pharmaceutical quality and highlight ways in which innovations have been embraced in a changing world. Speakers will:

  • Share lessons learned from the COVID-19 public health emergency.
  • Describe recent regulatory innovations related to pharmaceutical quality.
  • Connect science and research to regulatory actions.
  • Explain how the FDA is supporting the use of new technologies in the manufacture of pharmaceuticals.


TOPICS COVERED

  • Learning From the COVID-19 Public Health Emergency, including a panel discussion of FDA leaders
  • Innovations at FDA
  • A Foundation of Science
  • Advancing Advanced Manufacturing

 

INTENDED AUDIENCE

  • Healthcare professionals interested in the FDA’s work on pharmaceutical quality.
  • Manufacturing professionals
  • Regulatory affairs professionals
  • Foreign regulators

 

FDA RESOURCES

 
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