How to Prepare for and Manage an FDA Inspection
Susanne Manz is a Keynote Speaker at Compliance Key. 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. While at GE, Johnson and Johnson, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, World Wide Director of Quality Engineering, World Wide Director of Product Quality, and Director of Corporate Compliance.........
Overview
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.
Why should you attend this webinar?
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 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 benefit from this webinar.
Areas Covered in the Session:
- 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
Who can Benefit:
- Quality Engineers
- Compliance 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
Webinar Id: LSHCSM001
Past Webinar of Susanne Manz
Past Webinar: Life Sciences and Healthcare
