Regulatory Education for Industry (REdI):
Pharmaceutical Quality Symposium
October 26 & 27, 2021
The agenda may be updated as changes are made. The current version is Version 7, updated on October 25, 2021.
The speaker biographies document provides information about the event speakers.
Session Recordings:
- 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
- Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion
- 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
- 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
- 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
- Pharmaceutical Quality Symposium 2021 Part 6
- Keeping Products Safe for Consumers
- The State of Pharmaceutical Quality
- Panel Questions and Discussion
- Pharmaceutical Quality Symposium 2021 Part 7
- Emerging Technology Program 2.0
- Addressing the Advanced Manufacturing Regulatory Framework
- Panel Questions and Discussion
- 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
Questions?
Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.
More Information
If you have questions regarding the content of the event or other CDER-specific information, please:
- Visit the CDER SBIA website
- Learn more about CDER SBIA Workshops and Webinars
- Subscribe to the CDER SBIA email updates
- Follow us on LinkedIn