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  4. An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) - 05/24/2023
  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
May 24, 2023

Date:
May 24, 2023
Time:
9:00 AM - 2:00 PM ET

Topics & Presentations

Speakers

An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)

 

Introductory Remarks and Welcome.pdf

Jennifer Maguire, PhD
Director
Office of Quality Surveillance (OQS)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA

What is a Field Alert Report (FAR), Biological Product Deviation Report (BPDR) and Consumer Complaint? And How Do These Differ.pdf

Melissa Furness
Biologist
Division of Internal Policies and Procedures (DIPP)
Office of Policy for Pharmaceutical Quality (OPPQ)
OPQ | CDER | FDA

Expectations of Field Alert Report (FAR) and Biological Product Deviation Report (BPDR) Submissions.pdf

Elise Murphy
Supervisory, Consumer Safety Officer
Division of Quality Intelligence II (DQI II)
OQS | OPQ | CDER | FDA

Modernizing Post-Market Quality Surveillance Through Application of Advanced Analytics.pdf


Reporting Program Through the Application of Advanced Analytics.pdf

Alex Viehmann
Division Director
DQI II | OQS | OPQ | CDER | FDA

Nandini Rakala, PhD
Visiting Associate
DQI II | OQS | OPQ | CDER) | FDA

Question and Answer (Q&A) Panel

Jennifer Maguire, Melissa Furness, Elise Murphy, Alex Viehmann and Nandini Rakala

Report on the State of Pharmaceutical Quality (RSPQ).pdf

Neil Stiber, PhD
Associate Director for Science and Communication
OQS | OPQ | CDER | FDA

How are FARs/BPDRs utilized within Site Selection Model (SSM).pdf

John Wan
Supervisor
OQS | OPQ | CDER | FDA

Risk-based Facility Assessment for Pre-Approval Inspection Determination.pdf

Derek Smith, PhD
Deputy Director
Division of Pharmaceutical Manufacturing Assessment IV (DPMA IV)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
OPQ | CDER | FDA

Pharmaceutical Quality System (PQS) assessments.pdf

Alex Viehmann
Division Director
DQI II | OQS | OPQ | CDER | FDA

Post-Market Reports (FAR/BPDR) Site Dossiers.pdf

Milva Melendez
Supervisory Consumer Safety Officer
DQI II | OQS | OPQ | CDER | FDA

Question and Answer (Q&A) Panel

Neil Stiber, John Wan, Derek Smith, Alex Viehmann, and Milva Melendez

Closing Remarks

Jennifer Maguire

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

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