Beschreibung Pragmatic GXP Compliance: Successfully navigating the often complex and maddening world of regulatory inspections, inspection readiness, and knowing what’s important (English Edition). This is not a typical “GXP Compliance” book. It is not about the nuts-and-bolts of process validation protocols, cleaning validation, or training. However, it is a "must have" for individuals involved in driving GXP compliance, supporting regulatory compliance initiatives, or working in a GXP-regulated business. Here, you will find the help you need to comply thoroughly, efficiently, and effectively without employing the "above and beyond" approach that often serves as a barrier to success. In short, the intent of this book is to inject pragmatism into the complex web of GXP requirements and offer help navigating toward a more successful outcome. The temptation regarding GXP compliance is to comply plus… go above and beyond… just in case! However, this approach is cumbersome, expensive, and frustrating. Topics covered in this concise and easy-to-read work include: why does GXP compliance matter, not everything we do under the umbrella of "GXP Compliance" is really required (or even necessary), everything you need to know for regulatory inspection success, and the future of compliance and regulatory inspection. In addition, 37 recommendations are included which should help you drive toward that optimal and effective state of GXP compliance.
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