[formidable id="4" title="1" description="1"] The Top 5 FDA Violations & How to Prevent Them Watch our discussion on how to react to FDA violations and how to prevent them from the beginning. This free webinar addresses the top violations cited by FDA Inspectors in the following industries: Medical device Pharma / Drug / OTC ...
[formidable id="6" title="1" description="1"] The Monumental Power of MDSAP Certification Worried about the FDA knocking on your door? Wish you could protect your company from unwarranted inspections? Did you know the FDA has endorsed: • ISO 13485:2016 as the basis of the QMSR? • MDSAP certification? Did you also know MDSAP ce...
[formidable id="1" title="1" description="1"] 3 Critical Mistakes Made During Root Cause Investigations Ask yourself: How many nonconformities or customer complaints keep reoccurring? How many of your root cause investigations only dealt with the problem’s symptoms? If your answer is higher than 1 or 2, then your company is pro...
[formidable id="3" title="1" description="1"] 5(+1) Most Important Auditing Mistakes Most Internal Auditors Make Does the thought of conducting an internal audit make you sweat? You’re not alone. Auditing should be a positive and productive experience for all involved. But due to inexperience and lack of training, internal auditors frequentl...
[formidable id="7" title="1" description="1"] Transitioning from MDD to MDR – 3 Pitfalls to Avoid Do you know what pitfalls most medical device manufacturers are experiencing as they RUSH to get their devices approved and transition from MDD to MDR? Using old documents and records thinking they will be approved. Getting Nonconform...
[formidable id="6" title="1" description="1"] Failures of the 3 Core Quality System Processes To have an effective and value-additive Quality System, it MUST have these 3 quality system processes working seamlessly: Problem Identification Process Problem Resolution Process Management Review But what if they don't? In this w...
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