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Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance
     

Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

by Mindy J. Allport-Settle
 
Manage regulatory commitments, meet key deliverable dates, generate supporting data reports, support the financial forecasting process. This remediation project management guide provides a systematic approach to managing and tracking the multiple projects typically required to re-establish cGMP compliance. It emphasizes up-front planning for every aspect of site

Overview

Manage regulatory commitments, meet key deliverable dates, generate supporting data reports, support the financial forecasting process. This remediation project management guide provides a systematic approach to managing and tracking the multiple projects typically required to re-establish cGMP compliance. It emphasizes up-front planning for every aspect of site remediation and compliance upgrade by focusing on managing activities to a series of targeted milestones. Data-driven reports and documentation facilitate communication between the company and regulatory agencies on the path to quality compliance. This system is the benchmark process for leading regulatory compliance efforts and its successful implementation will create a platform for profitability for the company. Includes FDA reference documents.

Product Details

BN ID:
2940011814686
Publisher:
PharmaLogika
Publication date:
01/18/2005
Sold by:
Barnes & Noble
Format:
NOOK Book
Pages:
220
File size:
1 MB

Meet the Author

Following in the footsteps of Gordon Allport, all of Mindy J. Allport-Settle's books are built on a foundation of psychology and sociology with a focus on improving some aspect of industry through research and education. Her career in healthcare began when she was a teenager working as an emergency medical technician. Since then, she has joined the U.S. Navy's advanced hospital corps, worked in organ and human tissue procurement, specialized in ophthalmology, and moved on to serve as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development and product commercialization strategies, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology. Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.

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