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FDA’s Adverse Event Reporting and Product Recalls

This course enables professionals to strengthen compliant complaint handling and adverse event reporting systems while aligning recall processes, supporting centralized management, regulatory reporting accuracy, and inspection readiness within FDA-regulated pharmaceutical and medical device environments. This Course is designed for professionals involved in complaint handling, regulatory reporting, quality systems, and recall management within regulated industries.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Joy Mcelroy
  • Study time : 75 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3051
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Regulated organizations must establish structured systems for managing complaints, adverse events, and product recalls in line with FDA expectations. Effective programs define complaint sources, documentation standards, and the relationships between complaint handling and recall decision-making. Understanding reporting timelines for adverse events remains essential to maintaining compliance and ensuring timely regulatory communication across pharmaceutical and medical device operations.


Systems must support electronic submission and structured management of adverse event reports, ensuring alignment with integrated complaints management frameworks. Centralized control of reporting processes enables consistent tracking, documentation, and regulatory submission across all product-related issues. GMP requirements for complaint documentation and recall systems define expectations for procedural control, organizational readiness, and resource allocation. FDA inspection activities frequently evaluate complaint handling effectiveness, adverse event reporting accuracy, and recall preparedness, making systematic compliance execution essential for regulated organizations. Failure to meet reporting requirements can lead to regulatory consequences.

  • Regulatory Alignment in Complaint and Adverse Event Reporting:

    Gain clarity on FDA expectations for complaint handling, adverse event reporting, and recall linkage within regulated quality systems. The course supports accurate documentation practices, structured reporting timelines, and alignment of procedural controls, helping professionals maintain compliance consistency across pharmaceutical and medical device operations while addressing regulatory scrutiny during inspections.

  • Recall System Readiness and Inspection Preparedness:

    Understand requirements for establishing recall systems supported by GMP-aligned documentation and operational procedures. Emphasis is placed on organizing resources, defining responsibilities, and ensuring readiness for regulatory evaluation. This improves ability to respond to adverse event signals, manage recall actions, and demonstrate structured compliance during FDA inspection reviews.

Key Areas Covered

  • GMP requirements for complaint documentation and management
  • Sources of complaints and structured complaint handling processes
  • Interrelationship between complaint handling and product recall activities
  • FDA requirements for complaints, adverse events, and recalls
  • Reporting requirements and timelines for adverse event submission
  • Requirements for establishing a compliant complaint management system
  • GMP standards and procedural controls for effective recall systems
  • FDA inspection focus areas including reporting accuracy and compliance consequences

Who Must Attend

  • QA/QC Departments
  • Operations Departments
  • Production Departments
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Process Development Professionals

Quality training, expert insights, and answers that matter. Know your Expert

JOY MCELROY

Joy Mcelroy brings extensive pharmaceutical and biotechnology experience spanning quality control, quality assurance, and GMP compliance roles. Her background includes environmental monitoring, sterility testing, QA auditing, batch record review, and validation activities such as equipment qualification and cleaning validation. She has supported regulatory-focused documentation and training initiatives, aligning with compliance expectations. Her consulting and training work supports organizations in strengthening GMP systems relevant to complaint handling, adverse event reporting, and recall readiness.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Our students love us ❤️

“Some parts we already knew, but the way it was explained made it easier to apply. We ended up revisiting our internal approach after this.”

Regulatory Affairs Manager

“Examples were relatable. Not generic. We could map it to what we are currently doing.”



Supervisor, Quality Control

“Slides were clear. No clutter. That made it easier to stay focused.”




Analyst, QA

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