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
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.
Use Promo Code XMSNY19 and get flat 20% discount on
all purchases.
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