Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries
Medical instruments and apparatus industry Medical instruments and apparatus Pharmaceutical industry Drug Industry Biotechnology Consumer Product Safety Cost Control Equipment and Supplies Quality Assurance, Health Care e-böcker
John Wiley & Sons
2011
EISBN 9780470933503
Controlling regulatory costs.
Clear operation definitions of requirements.
Pre-regulatory audits.
Quality by design.
Outsourcing.
Electronic submissions.
Emea/fda coordination.
Managing FDA inspections.
Risk assessment.
Cases.
Cost containment analysis.
Managing regulation in times of chaos.
International regulation.
Cost contained regulatory compliance.
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
Clear operation definitions of requirements.
Pre-regulatory audits.
Quality by design.
Outsourcing.
Electronic submissions.
Emea/fda coordination.
Managing FDA inspections.
Risk assessment.
Cases.
Cost containment analysis.
Managing regulation in times of chaos.
International regulation.
Cost contained regulatory compliance.
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
