Symposium | Virtual

Event Title

Pharmaceutical Quality Symposium 2021: Innovations in a Changing World

October 26 - 27, 2021

Scheduled

Date:: October 26 - 27, 2021
Day1:: Tue, Oct 26 9:00 a.m. - 04:00 p.m. ET
Day2:: Wed, Oct 27 8:45 a.m. - 03:15 p.m. 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

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