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Since 1978, the Good Laboratory Practice (GLP) regulations have been a cornerstone of the industry, and with the proposed FDA amendment, it’s essential to stay ahead of the curve. This comprehensive guide provides a unique opportunity to delve into the interpretation of 21CFR58 regulatory requirements from renowned industry experts.
This valuable resource takes the regulations and provides in-depth interpretations, accompanied by references to examples and regulatory actions. The expert authors share their vast knowledge and expertise, ensuring that readers gain a thorough understanding of the GLP regulations and their practical applications.
Data integrity is a critical aspect of GLP, and the use of electronic systems is becoming increasingly prevalent. This book provides detailed guidance on compliance with 21CFR11 Electronic Records: Electronic Signatures, ensuring that readers are well-equipped to manage electronic data in a GLP-compliant manner.
One of the unique strengths of this book is its focus on FDA inspections of GLP facilities. Readers will gain valuable insights into the latest requirements and best practices for ensuring compliance during inspections.
This comprehensive guide also covers the critical topic of GLP and computer systems validation, providing readers with a thorough understanding of the requirements and implementation strategies.
As a valuable reference, this book can be repeatedly consulted to support daily, hands-on implementation of the CFR requirements. With its detailed guidance and expert insights, it’s an essential resource for anyone involved in the GLP industry.
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