Preparing for an FDA Inspection - What you Need to Know
In this webinar you will learn how to manage inspections efficiently and effectively, Also you will learn how to present information about your quality system in the most competent and professional manner, 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.
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:
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 benefit from this webinar.
Learning Objectives:
- FDA Inspection approach
- Inspection preparedness strategy and planning
- Key roles during an inspection
- SME (Subject Matter Expert) training
- Checklists for preparing
- How to manage an inspection
- Common mistakes to avoid
- How to respond to inspection observations
Who Will 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
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.