Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on August 27 for a discussion of the webinar

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 create an inspection readiness plan, so you are well prepared for an FDA inspection. 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.   

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 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.

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

Can't Make this LIVE Webinar?

Simply select the Recorded option when registering and we will send you the link to view the recorded version.

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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Faculty Susanne Manz

Faculty 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. 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.

Choose a Purchase Options

$287

Live Webinar - Single Participant 90-mins

Special Offer Attend live and get Free Recorded Access for 6 month

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$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

$399

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.