Best Practices for Managing an FDA Inspection

  • Speaker:Susanne Manz
  • Duration:75Min
  • Product Code:GRC-90094

Live Session - How it works

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  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
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  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

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Description:

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 plan 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 basics
•    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

Instructor Profile:
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 and has a BS in Biomedical Engineering and an MBA from the University of NM.  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 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.  For more information, visit www.ManzConsultingInc.net.

Available Options

Recording: 6 Months Access to the Training which can be accessed from any location

$229

CD-DVD: Shipped within 2 working days

$349

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$1,469

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$2,349

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