Shoping cart:
Empty
Cheap Software
Search by Letter:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All programs New Mac

Cost-Contained Regulatory Compliance For the Pharmaceutical, Biologics, and Medical Device Industries PDF eBook

10$
Buy!Download Size: 1.86 MB


Sandy Weinberg - Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries
Published: 2011-05-31 | ISBN: 0470552352 | PDF | 296 pages | 3 MB


Proven strategies and case studies on how to contain regulatory costs in the healthcare industries
This book outlines a comprehensive strategy for controlling the cost of regulatory compliance in the pharmaceutical and medical industries. It provides professionals in the field with the tools they need to cut costs in submissions, compliance, and regulatory affairs while maintaining the quality and safety of their products.
Drawing on decades of regulatory experience, the author identifies eight field-tested strategies designed to eliminate redundancy, waste, uncertainty, inertia about regulatory guidelines, and other areas that add cost without adding value. He uses real-world case studies to illustrate the techniques, offering analysis and advice on implementation in different circumstances and industries. Copies of official documents from the FDA and other agencies are also included.
Readers will find no-nonsense, practical tips, and guidelines on how to:
Clarify requirements to avoid overly zealous or "just to be safe" compliance that exceeds regulatory expectations
Reduce FDA response and review time through independent audits and the adoption of electronic submissions
Devise a simultaneous submission strategy to deal with FDA/EMA overlap
Automate the quality control process through the use of Quality by Design (QbD) systems
Use outsourcing in a constructive way to reduce overhead and tap outside expertise
Take a proactive approach to FDA inspections and investigations and utilize risk-assessment management techniques



Cost-Contained Regulatory Compliance For the Pharmaceutical, Biologics, and Medical Device Industries PDF eBook

10$
Buy!Download Size: 1.86 MB


Customers who bought this program also bought:




Software Store Deal of the Day

2010 SUPER PACK 4

2010 SUPER PACK 4

Unclude: Adobe Acrobat 9.0 Pro Extended (1 dvd), Adobe Photoshop CS5 Extended 12.0 (1 dvd), Autodesk Autocad LT 2011 (1 dvd), Corel WinDVD Pro 2010 10.0.5.291 Multilingual, CorelDRAW Graphics Suite X5 15.0.0.486, DVD Cloner VII 7.10.992, TechSmith Camtasia Studio 7.0.0

Real PriceSaving Deal of the Day View it »
$2960 94.6%229$BUY!
We recommend
Categories
© 2010-2017. All rights reserved.