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Agenda

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ABOUT THIS WEBINAR

FDA CDER Office of Pharmaceutical Quality is offering a five-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.

TOPICS COVERED

• Post-market reporting (FARs and BPDRs) requirements and expectations – who is responsible for reporting, how do you report, and what happens if they are not reported
• FDA’s use of post-market quality defect reports to support risk-based decisions
• The parameters of OPQ’s assessment for FARs and BPDRs (i.e., how are they assessed and what is the overall business process OPQ manages
• The integration of advanced analytics into OPQ’s post-market quality defect report program

LEARNING OBJECTIVES

• What are the post-market reporting requirements and expectations for application holders and manufacturers.
• How does FDA manage and assess the reports.
• What to expect regarding follow-ups and engagement from FDA after submitting a report.
• How does FDA utilize FARs/BPDRs to support regulatory decisions (e.g., surveillance inspection prioritization, pre-approval/pre-license inspections, regulatory flexibility, etc.).
• How does FDA integrate FARs/BPDRs into their overall assessment on the state of pharmaceutical quality.
• How is FDA innovating processes for managing FARs/BPDRs with the integration of advanced analytics.

INTENDED AUDIENCE

• NDA, ANDA, BLA applicant holders
• Generic and New Drug Pharmaceutical manufacturers (including CDMOs)
• Contract Testing Laboratories
• Regulatory Affairs professionals supporting post-marketing reporting requirements
• Quality Assurance and Quality Control professionals
• Consultants supporting pharmaceutical manufacturers
• Foreign Regulators

FDA RESOURCES

• 21 CFR 314.81
• 21 CFR 600.14
• Field Alert Reports
• CDER – Biological Product Deviations

CONTINUING EDUCATION

This webinar has been approved for 4.75 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

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 webinar 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.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.