Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Whether preparing for regulatory submissions or preapproval, investigator-directed, routine or foreign inspection, this book is assured to enhance the facility- and compliance-readiness of any company requiring a strengthened approach to compliance and total quality management. Providing innovative programs for every key quality system within an FDA environment, this guide evaluates critical compliance and quality challenges within the context of FDA expectations, current industry standards and emerging global trends.
Reveals the necessary tools to identify, interpret and prevent FDA regulatory crises.
Offering the critical perspectives and guidelines required to complete globally and meet changing FDA and regulatory demands, Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics discloses proven strategies and practical recommendations from field insiders that guarantee improved compliance and quality in areas such as method development, computer and process validation, change management, internal auditing, product reviews and regulatory strategic planning. It presents models for success in personnel training, process validation, SOP compliance, laboratory and manufacturing operations and vendor qualification. It also introduces the latest interpretation of the FDA's new GMP initiative, illustrates quality assurance systems for durable compliance and offers programs sure to significantly decrease compliance vulnerability and regulatory liability.
Printed in the United States of America
Available through Marcel Dekker, Inc.
