Due Diligence of Quality Systems for Medical Device Companies

Duration: 90 Minutes
This webinar will focus on Due Diligence with respect to Quality System requirements. We will discuss what to look for, how to prioritize your activities, and what to report to management. We'll discuss methods for prioritizing findings by risk and creating action plans.
Instructor: Susanne Manz
Product ID: 501085
Mergers and acquisitions are an on-going and important part of the medical device industry; Due Diligence is a critical part of that process, setting the stage for either success or disaster. Poor due diligence can lead to quality (ex. Recalls) or compliance (ex. Warning letter or Consent Decree) problems months or years after an acquisition.

Objectives of the Presentation
  • Understand Due Diligence with respect to Quality System requirements
  • Understand the process and expectations for Due Diligence
  • Understand how to conduct a Due Diligence inspection
  • Understand how to document and Report Results
  • Understand what to report to management
  • How to create a meaningful action plan for integration teams
Why Should you Attend
Inadequate Due Diligence is not only a missed opportunity but can also lead to disaster months or even years later. Recalls, Warning Letters, Consent Decrees, and significant financial losses can be the result of inadequate Due Diligence. This course will quickly help you avoid that disaster and help you improve your business success.

Areas Covered
  • Due Diligence expectations and planning
  • Team requirements
  • Lessons learned from acquisitions
  • Red Flags of quality / compliance issues
  • How to categorize / prioritize Issues
  • Check list for Due Diligence
  • Risk Management
  • Preparing recommendations for M&A
  • Preparing action plans for post-acquisition
Who can Benefit
  • Quality or Compliance personnel conducting Due Diligence
  • Business development personnel wanting to understand Quality and Compliance aspects of Due Diligence
  • Integration Teams
$375
Recorded Session for one participant
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  $500.00 Training CD
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 CQA (Certified Quality Auditor) 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.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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