Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing October 31, 2023 - November 1, 2023

Symposium | Virtual

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• Date: October 31, 2023 - November 1, 2023
• Day1: Tue, Oct 31 9:00 AM - 4:30 PM ET
• Day2: Wed, Nov 1 9:00 AM - 3:45 PM ET

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Topics & Presentations Day 1	Speakers
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 1
FDA Keynote Address	Robert Califf, MD Commissioner of Food and Drugs Food and Drug Administration
Office of Pharmaceutical Quality Keynote.pdf	Michael Kopcha, PhD, RPh Director Office of Pharmaceutical Quality (OPQ) | CDER
State of Pharmaceutical Quality.pdf	Neil Stiber, PhD Associate Director for Science and Communication Office of Quality Surveillance (OQS) OPQ | CDER
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 2
Quality Assessment Updates.pdf	Sau “Larry” Lee, PhD Deputy Director of Science OPQ | CDER
Patient - Focused Specifications.pdf	Susan Kirshner, PhD, MSc Division Director Office of Biotechnology Products (OBP) OPQ | CDER
Modernizing Quality Assessment of New Drugs.pdf	Hong Cai, PhD Division Director Office of New Drug Products (ONDP) OPQ | CDER
Collaborating for Generic Drug Development and Approval Success: A Regulatory Perspective.pdf	Yue “Helen” Teng, PhD Division Director Office of Lifecycle Drug Products (OLDP) OPQ | CDER
Q&A Discussion Panel	Same as above
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 3
Inspections in a Post-Pandemic World.pdf	Alonza Cruse Director Office of Pharmaceutical Quality Operations (OPQO) Office of Regulatory Affairs (ORA) | FDA
Pre-license Inspections: What Industry Should Know.pdf	Christopher Downey, PhD Supervisory Chemist Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER
Q&A Discussion Panel	Same as above
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 4
Overview of Policy Document Options, Development, and Oversight.pdf	Leila Wieser Director | Editorial and Project Management Staff Office of Policy for Pharmaceutical Quality (OPPQ) OPQ | CDER
International Harmonization: Ensuring Availability of Quality Medicine.pdf	Theresa Mullin, PhD Associate Director for Strategic Initiatives CDER
ICH Q12 Implementation: What Does Industry Need to Know.pdf	Mahesh Ramanadham, PharmD, MBA CDR | USPHS Deputy Director OPPQ | OPQ | CDER
Nitrosamine Research Studies Inform FDA on Potential Strategies and BE Approaches.pdf	Dongmei Lu, PhD Pharmacologist OPPQ | OPQ | CDER
USP & FDA: A Symbiotic Relationship to Ensure Quality.pdf	Pallavi Nithyanandan, PhD Director OPPQ | OPQ | CDER
Not So Complex? Product-Specific Guidance Updates.pdf	Xiaoming Xu, PhD Division Director Office of Testing and Research (OTR) OPQ | CDER
Q&A Discussion Panel	Same as above
Day One Closing	Adam Fisher, PhD Director of Science Staff OPQ | CDER

 

Topics & Presentations Day 2	Speakers
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D2 – Part 1
Featured Presentation: Project ORBIS.pdf	Angelo De Claro, MD Division Director Office of Oncologic Diseases (OOD) Office of New Drugs (OND) | CDER
Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.pdf	Matthew Dionne, PharmD CAPT | USPHS Compliance Officer Office of Manufacturing Quality (OMQ) Office of Compliance (OC) | CDER
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing.pdf	Timothy Pohlhaus, PhD Consumer Safety Officer OMQ | OC | CDER
Q&A Discussion Panel	Matthew Dionne and Timothy Pohlhaus
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D2 – Part 2
Quality Management Maturity.pdf	Nandini Rakala, PhD, MS Visiting Associate & Data Scientist Office of Quality Surveillance (OQS) Office of Pharmaceutical Quality (OPQ) | CDER
Drug Quality Sampling and Testing.pdf	Stephen Cahill, MBA Operations Research Analyst OQS | OPQ | CDER
CDER Site Selection Model.pdf	John Wan, MBA Supervisory Operations Research OQS | OPQ | CDER
Q&A Discussion Panel	Nandini Rakala, Stephen Cahill, John Wan,  And Wendy Wilson, PhD Deputy Office Director OQS | OPQ | CDER
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D2 – Part 3
CDER’s Emerging Technology Program.pdf	Tom O’Connor, PhD Deputy Director Office of Testing and Research (OTR) OPQ | CDER
FRAME: Supporting Advanced Manufacturing Technologies.pdf	Adam Fisher, PhD Director of Science Staff OPQ | CDER
Implementation of ICH Q13 Continuous Manufacturing Guidance.pdf	Rapti Madurawe, PhD Division Director Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER
Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities.pdf	Geng “Michael” Tian, PhD LCDR | USPHS Branch Chief OTR | OPQ | CDER
AI in Manufacturing of Pharmaceutical Products: Challenges and Opportunities.pdf	Jayanti Das, PhD Research Scientist OTR | OPQ | CDER
Q&A Discussion Panel	Same as above
Closing Remarks	Michael Kopcha, PhD, RPh Director Office of Pharmaceutical Quality (OPQ) | CDER

 

Agenda

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ABOUT THIS EVENT

Pharmaceutical quality assures the availability, safety, and efficacy of every dose of medicine. Everyone deserves confidence in their next dose of medicine. Problems with pharmaceutical quality can impact the availability of medicine to patients and consumers. The mission of CDER’s Office of Pharmaceutical Quality (OPQ) is to assure quality medicines are available to the American public. This symposium, held every two years, will explore topics related to pharmaceutical quality regulation, supply chains, and advanced manufacturing technologies. Attendees will become familiar with the regulatory quality assessment, inspection, policy, surveillance, and research activities that impact the pharmaceutical supply chain and assure drug quality.

Learn more about the FDA’s pharmaceutical quality toolbox. OPQ’s quality assessment of drug applications uses tools that streamline risk assessment and knowledge management. OPQ policy conveys the most current thinking on pharmaceutical quality topics to enable manufacturers to provide high-quality drugs. Market surveillance and enforcement tools work to support the health of pharmaceutical supply chains while protecting the public. Programs focused on advanced pharmaceutical manufacturing provide tools for regulators and drug developers so that patients and consumers can benefit from promising new technologies. This pharmaceutical quality toolbox helps assure that quality medicines are available to the American public.

INTENDED AUDIENCE

• Manufacturing professionals focused on drug products, including new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) marketed in the U.S. and regulated by CDER
• Regulatory affairs professionals interested in FDA’s pharmaceutical quality policy and surveillance programs
• Foreign regulators and other international bodies interested in pharmaceutical quality harmonization
• Healthcare professionals and others interested in medicine quality, the U.S. supply chain, and advanced pharmaceutical manufacturing technologies

TOPICS COVERED

• Quality assessment of drug product marketing and licensing applications and how it relates to FDA innovations and facility evaluations
• Pharmaceutical quality policy and how new domestic and international efforts drive toward improved quality outcomes for patients and consumers
• Pharmaceutical supply chains and how FDA market surveillance activities help to assure drug quality
• Advanced pharmaceutical manufacturing technologies and how FDA is preparing for industry’s use of technologies such as AI for pharmaceutical manufacturing

FDA RESOURCES

• Protecting Patients & Consumers from Drug Quality Risks (video)
• FDA’s Office of Pharmaceutical Quality
• CDER’s Drug Quality Sampling and Testing Programs
• 2022 Report on the State of Pharmaceutical Quality
• Pharmaceutical Quality Resources
• Framework for Regulatory Advanced Manufacturing Evaluation
• Emerging Technology Program