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Ensuring your Site is Ready for an FDA Inspection

This course strengthens inspection readiness for medical device companies by improving inspection planning, SME response consistency, and post-inspection corrective communication. It helps teams reduce avoidable compliance exposure linked to FDA 483 observations and warning letters. This Course is designed for professionals responsible for quality systems, inspection coordination, compliance activities, and regulatory inspection preparedness.

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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 : Susanne Manz
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3122
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

FDA inspections continue to result in 483 observations and warning letters for medical device companies, often due to avoidable quality system and communication failures. Organizations are expected to maintain a state of inspection readiness, yet many teams struggle with preparation, inspection coordination, and consistent responses under regulatory scrutiny. Poor handling of inspection interactions can increase compliance exposure and create unnecessary operational disruption.


This course focuses on practical inspection preparation activities before, during, and after an FDA inspection. Attention is given to planning responsibilities, announced inspections, area-specific checklists, and common mistakes that frequently contribute to compliance concerns. The course also addresses preparation of Subject Matter Experts to communicate clearly and factually during inspections, along with guidance for developing appropriate responses to FDA 483 observations following the inspection process. The material supports more controlled inspection management and better internal coordination across quality and compliance functions.

  • Strengthen Inspection Response Coordination:

    Develop a more controlled approach to inspection preparation, onsite interactions, and post-inspection follow-up activities. The course clarifies how to organize inspection planning efforts, manage announced inspections, and prepare Subject Matter Experts to respond consistently and factually. These capabilities are critical as FDA observations continue affecting medical device companies with avoidable compliance deficiencies.

  • Improve Quality System Presentation During Inspections:

    Gain practical direction for presenting quality system information clearly during FDA inspections while avoiding common procedural and communication mistakes. The course addresses activities before, during, and after inspections, including development of appropriate FDA 483 responses. Stronger inspection handling can reduce unnecessary escalation and support more effective regulatory communication.

Key Areas Covered

  • General FDA inspection expectations for medical device companies
  • Common inspection mistakes leading to compliance concerns
  • Inspection planning and pre-inspection preparation activities
  • Managing announced inspections and internal coordination activities
  • Area-specific inspection checklists and documentation preparation
  • Preparing Subject Matter Experts for factual inspection communication
  • Activities and conduct expectations during the inspection process
  • Guidance for responding appropriately to FDA 483 observations after inspections

Who Must Attend

  • Quality Assurance Departments
  • FDA Inspection Coordinators
  • Compliance Managers
  • Regulatory Affairs Departments
  • Operations Managers
  • Manufacturing Departments

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

SUSANNE MANZ

Susanne Manz is an experienced medical device quality and compliance professional with expertise spanning product development, operations, and post-market activities. Her background includes quality systems, regulatory compliance, and six sigma implementation within the medical device industry. She holds a BS in Biomedical Engineering, an MBA, RAC certification from RAPS, and CQA certification from ASQ. Her experience preparing organizations for quality and compliance expectations directly supports the inspection readiness and FDA interaction topics addressed in this webinar.

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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.”

Senior Manager, Regulatory Affairs


“Session was easy to follow even for non-core team members. That helped.”



Quality Assurance Specialist

“Useful for our current stage. Timing worked out well for us.”




Compliance Consultant

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