FDA Pharmaceutical Quality Symposium 2021: Innovations in a Changing World

Date:

Day1:Tue, Oct 26 9:00 AM-4:00 PM ET
Day2:Wed, Oct 27 8:45 AM-3:15 PM ET

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

• FDA’s Office of Pharmaceutical Quality
• Report on the State of Pharmaceutical Quality: Fiscal Year 2020
• FDA’s Office of Pharmaceutical Quality Annual Report: 2020
• Pharmaceutical Quality Resources
• Facts About the Current Good Manufacturing Practices (CGMPs)

CONTINUING EDUCATION
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.