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      How to Prepare for and Manage an FDA Inspection in Middletown

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      February 24, 2020

      Monday   1:00 PM - 2:30 PM

      Compliance Key,364 E Main Street, Suite 1009
      Middletown, Delaware 19709

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      How to Prepare for and Manage an FDA Inspection

      Topic : How to Prepare for and Manage an FDA Inspection

      Register :

      Discount Coupon : Use this Coupon (NEW2COMPLIANCE ) and get (10% Off) On New Signup


      Are you ready for the FDA to knock on your door? 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.

      Areas Covered in the Session :

      FDA Inspectional approach
      Inspection strategy and planning
      How to manage an inspection
      Key roles during an inspection
      Training for SMEs (Subject Matter Experts) and other roles
      Do's and Don'ts
      Common mistakes to avoid
      How to respond to inspection observations

      Speaker Profile :

      Susanne Manz is a Keynote Speaker at Compliance Key. 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, Johnson and Johnson, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, World Wide Director of Quality Engineering, World Wide Director of Product Quality, and Director of Corporate Compliance.

      Contact Info :
      Compliance Key
      Email :
      Phone : +1 717-208-8666

      Categories: Conferences & Tradeshows | Education

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