Pharmaceutical Facilities and Equipment Management: Memory Jogger

REGULATORY JOGGER (TM) PHARMACEUTICAL FACILITIES AND EQUIPMENT MANAGEMENT Twenty 483 Observations On Facilities And Equipment Management That You Should Know! If your Quality Auditors were half as good as they think they are, there would not be the 54.1% chance of your operation receiving a FDA's 483 Letter. Can you deal with a fifty-fifty Industry efficiency? There is a better way. Our team has study dozens of FDA 483 Letters, and using our proprietary actuary model, have come up with expertly chosen Summaries that condense the FDA’s observations in an easy and practical format for the different regulatory roles. As a professional you need to know, for yourself, what the FDA is focusing when managing Facilities and Equipment issues, in addition to how to effectively justify your projects with the bean counters. You will find here: * TWENTY FDA Observations for Facilities and Equipment. * When, to whom and technical comments on the importance of the observations. * Deep Understanding of the FDA’S focus when addressing Facilities and Equipment issues. * Training material for Facilities, Utilities, and Equipment Engineers. * Regulatory Justification for Facilities and Equipment projects like: *HVAC systems, Filtration Systems, PLCs, Computer Maintenance Management Systems, staffing additions, training budgets, roof, floor, racks, piping, electrical, slat-walls, and much more. About the Editor Born on New York and raised in Puerto Rico, Dave Cortes is a professional engineer, certified Lean Black Belt and Project Management Professional. He has worked on Pharmaceutical and Medical Device industry for the past 16 years. His experience includes working on Fortune 1,000 companies like Johnson and Johnson, Pall Healthcare and Cardinal Health.