Due Diligence of Quality Systems for Medical Device Companies
Duration : 90 Minutes
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. She has a BS in Biomedical Engineerin Read more
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. 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.
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.
Course Objective:
• 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
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality or Compliance personnel conducting Due Diligence
• Business development personnel wanting to understand Quality and Compliance aspects of Due Diligence
• Integration Teams
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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