FDA CDER Office of Pharmaceutical Quality is offering a four-hour webinar to discuss reporting requirements and expectations for Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR). The statutory reporting requirements are found in 21 CFR 314.81 (for FAR) and 21 CFR 600.14 (for BPDR). FDA will share how it assesses these reports and how they support risk-based decisions in a variety of contexts. These reports provide an early warning signal to the agency that a marketed product may harm patients due to a deviation or incident that has occurred.

This webinar will present FDA expectations for conducting root cause analysis and then implementing and assessing effectiveness of corrective action and preventive action plans (CAPAs) to mitigate the severity and probability of harm. Attendees will learn how the agency is integrating advanced analytics (e.g., machine learning and natural language processing) to innovate processes and facilitate proactive approaches to quality risk management. FDA will also share some common reporting errors as well as best practices for report submission.

• 21 CFR 314.81 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.81
• 21 CFR 600.14 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=600.14
• Field Alert Reports - https://www.fda.gov/drugs/surveillance/field-alert-reports
• CDER – Biological Product Deviations - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-biological-product-deviations

• Describe the post-market reporting requirements and expectations for application holders and manufacturers.
• Cite how FDA manage and assess Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
• Discuss the expected follow-ups and engagement from FDA after submitting a report.
• Explain how FDA utilizes Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) to support regulatory decisions.
• Identity how FDA integrates Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) into their overall assessment on the state of pharmaceutical quality.
• Discuss how FDA is innovating processes for managing Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) with the integration of advanced analytics.

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

• Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
• Furness, Melissa, Biologist/Policy Lead, FDA/CDER/OPQ/OPPQ/DIPAP - nothing to disclose
• Maguire, Jennifer, PhD, Office Director, CDER/OPQ/OQS - nothing to disclose
• Melendez, Milva, BS Chemical Engineer, Supervisor Consumer Safety Officer, FDA - nothing to disclose
• Murphy, Elise, Supervisor, Consumer Safety Officer, FDA - nothing to disclose
• Rakala, Nandini, PhD, MS, BS, Visiting Associate - Data Scientist, CDER-OPQ-OQS-DQI-II - nothing to disclose
• Smith, Derek, PhD, Deputy Director, CDER/OPQ/OPMA - nothing to disclose
• Stiber, Neil, PhD, Associate Director for Science and Communication, U.S. FDA / CDER / OPQ / OQS - nothing to disclose
• Viehmann, Alex, Division Director, FDA/CDER/OPQ/OQS - nothing to disclose
• Wan, John, MBA, Supervisor, Office of Quality Surveillance - nothing to disclose

• Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
• Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

• Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose