Wednesday, February 5, 2014

Consent Decree

Consent Decree- Being cave in of the consequence and non the paradox. meetings at a social club that was downstairs consent degree, I moldiness say that I have learned a lot. I often look at myself as organism part of the solution and not the task. The goal that I had for myself and the company was to reveal areas that need improvement. In other words, look to visualise where the problems were and identify them with my superior. Part of my responsibilities was to review final documentation for truth forwards they are archived. As I go with these documentations, the errors that often observe were always the very(prenominal) (problem # 1). First of many an(prenominal) questions: Why is the same mistake happening over and over? Is it lack of tuition among departments? Are people rushing to all over an judge? Are they spending time to review their work? What is the problem? Root cause? In my opinion, and I am reliable several exit share the same opinio n, I confide that most companies receive FDA warning letter and or under a consent decree simply because of (1) interim fixes. What do I mean by temporary fixes? I fagged a lot of time sending documents can to the genius or department for re-review which sometimes might resolvent in a deviation. The problem on-hand will be address; provided the ascendant cause of why this is happening isnt being addressed. Therefore, this problem notes on accumulating until one day the FDA knocks on your doors and numeral a 483. Being part of the solution and not the problem: This simply means; we should stop pointing fingers, and bind to the solid root cause of the problem. Identifying and coming up with the best solution will help keep consistency on a respect basis. Helping with documentation is important because as a biotech pains customers come first. All cases patients need their medication, so an industry should keep in mind the importance of their job.If you want to get a full essay, order it on our website: OrderEssay.net

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