COURSE - INSTANT STREAMING ACCESS
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Post-Market Surveillance and Real-World Evidence

This course equips professionals to strengthen post-market surveillance systems through effective complaint handling, adverse event analysis, and risk monitoring. Participants gain practical methods to maintain regulatory readiness, improve product oversight, and support patient safety throughout the product lifecycle. This Course is designed for professionals responsible for product oversight, compliance, safety monitoring, quality systems, and regulatory coordination.

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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 : Meredith Crabtree
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3116
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Post-market surveillance plays a central role in maintaining the safety, effectiveness, and regulatory compliance of medical devices and pharmaceutical products after commercial release. Real-world product use introduces variables that may not emerge during pre-market evaluation, making ongoing monitoring essential for identifying adverse events, detecting risk patterns, and supporting timely corrective actions. Regulatory expectations under FDA and international requirements continue throughout the product lifecycle, requiring organizations to maintain reliable surveillance and reporting processes.


This course focuses on the operational and regulatory responsibilities involved in establishing and maintaining effective PMS systems. Key areas include complaint handling, adverse event reporting, post-market data analysis, risk assessment methodologies, and post-approval monitoring activities. The program also addresses cross-functional coordination among quality, regulatory, and product teams, along with collaboration involving healthcare professionals and regulators. Practical case studies demonstrate common implementation challenges and approaches used to maintain compliance, product performance oversight, and continuous quality improvement.

  • Strengthen Post-Market Risk Oversight:

    Participants will gain practical approaches for identifying product performance trends, evaluating adverse events, and managing complaints within regulated environments. The course connects post-market data analysis with risk assessment activities that support timely decision-making, regulatory reporting obligations, and ongoing product evaluation. Stronger surveillance practices help reduce operational exposure tied to unresolved safety or compliance concerns.

  • Improve Regulatory Readiness Across Product Lifecycles:

    The course provides working knowledge of post-market surveillance expectations tied to FDA requirements, EU MDR obligations, and ISO 13485:2016 quality system practices. Participants will better understand how coordinated processes across quality, regulatory, and product functions contribute to inspection preparedness, post-approval monitoring, and consistent handling of emerging product issues in commercial distribution.

Key Areas Covered

  • Post-market surveillance principles and ongoing product performance monitoring
  • FDA 21 CFR Part 820 and EU MDR expectations for PMS activities
  • Adverse event reporting requirements and complaint handling processes
  • Market monitoring, trend analysis, and identification of emerging product risks
  • Post-approval studies and risk assessment methodologies for real-world product use
  • PMS system practices aligned with ISO 13485:2016 quality management requirements
  • Case studies addressing implementation challenges and corrective action considerations
  • Coordination with healthcare professionals, regulators, manufacturers, and internal quality functions

Who Must Attend

  • QA/QC Departments
  • Pharmacovigilance  Officers
  • Research and Development Teams
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Risk Management Specialists

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

MEREDITH CRABTREE

Meredith Crabtree has more than 30 years of experience across regulated industries including pharma, medical devices, blood, tissue, laboratory, cosmetics, supplements, and animal health. Her background includes manufacturing, packaging, labeling, distribution, regulatory assessments, and quality training activities. As owner of MLKC Consulting, she supports organizations with product label reviews, third-party inspections, recall and Consent Decree support, and quality system evaluation activities directly connected to post-market oversight and regulatory compliance responsibilities.

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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 ❤️

“Examples felt practical instead of overly theoretical. The complaint handling discussion matched situations we actually deal with.”


Manager, Compliance Department

“Session stayed organized from start to finish. Helped connect risk monitoring activities with our internal quality processes.”


Senior Associate, QA Department

"Content was detailed enough and easy for cross-functional teams to follow.”


Supervisor, Research and Development Team

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