Ensuring Your Site is Ready for an FDA Inspection

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    Speaker: Susanne Manz


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    Duration: 90 Minutes
    Product Code: 51075
    Level: Intermediate

OVERVIEW

Although an effective Quality Management System should always be inspection ready, many medical device companies make basic mistakes during FDA inspections leading to 483s and even warning letters.  This webinar will help you create an inspection readiness plan, so you are well prepared for an FDA inspection.

WHY SHOULD YOU ATTEND

An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.  If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar.

AREAS COVERED

•  FDA Inspection approach
•  Ensuring your site is ready for an FDA inspection
•  Inspection preparedness strategy and planning
•  Key roles during an inspection
•  SME (Subject Matter Expert) training
•  FDA audit preparation checklist
•  How to manage an FDA inspection
•  Common mistakes to avoid
•  How to respond to inspection observations

LEARNING OBJECTIVES

This webinar can help you manage inspections efficiently and effectively.  You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for.  A professional, polished, responsive approach sets a good tone for an inspection.  You will learn how to present information about your quality system in the most competent and professional manner.

WHO WILL BENEFIT

•  Quality Engineers
•  Compliance Specialists
•  Compliance Managers and Directors
•  Management Representative
•  Quality Managers and Directors
•  Business Leaders wishing to present a professional and compliant organization
•  Cross-functional leaders wanting to make sure their organizations are well prepared
•  Anyone involved with an FDA or NB inspection

SPEAKER

Years of Experience: 30+ years

Areas of Expertise: Quality and Compliance for Medical Devices

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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