Knock, knock, who’s there? Are you ready for an FDA inspection?

What Regulatory, Quality & Compliance Professionals Need to Know

Webinar Online

Take your FDA Inspection to the next level of reliability with this webinar. WCS Course Instructor Susanne Manz, (MBA, MBB, RAC, CQA) FDA Consultant will create an inspection readiness plan, so you are well prepared for an FDA inspection.

Who should Attend.

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry and all FDA Regulated Industries personnel

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

Webinar Takeaway

  • 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

Overview

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 will 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.   


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 stress and lead to much more favourable 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.


Faculty Susanne Manz

Faculty Susanne Manz - 25+yrs exp.

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, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.

Susanne is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of NM. She is a certified Master Black Belt in Lean Six Sigma. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Choose a Purchase Options

$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session