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

 
9781448669752: Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance
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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.

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About the Author:

Mindy Allport-Settle has served as a key executive, board member, and consultant for some of the best companies in the pharmaceutical and associated regulated industry. Over her career, she has provided informed guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research & development and product commercialization strategies, operational, project and contract management, 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 designed for regulated industries. 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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