Best Practices for Preparing for an FDA Inspection
Duration : 90 Minutes
Susanne Manz,
Susanne Manz, MBA, MBB, RAC, CQA 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 Engineerin Read more
Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. 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.
Course Objectives:
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 a 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 Inspection. If you’ve had a recall, an increase in MDRs, or it’s been more than two years since your last inspection, you can benefit from this webinar.
Course Outline:
• FDA Inspectional approach
• Inspection strategy and planning
• Preparing
• How to manage an inspection
• Key roles during an inspection
• Training for SMEs (Subject Matter Experts) and other roles
• Do’s and Don’ts
• Common mistakes to avoid
• How to respond to inspection observations
What You get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Engineers
• Compliance Specialists
• CAPA Specialists
• Compliance Managers and Directors
• Quality Managers and Directors
• Consultants and Contractors
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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