This specific ISBN edition is currently not available.View all copies of this ISBN edition:
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.
Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures...gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents...and details the FDA’s GLP inspection program.
"synopsis" may belong to another edition of this title.
...an impressive achievement....a volume that should guide and influence those who plan to be perfect in acquiring a detailed education and review of the GLP requirements and desire to exercise responsibility in the Quality Control function.
-Current Engineering Practice (for previous edition)
"About this title" may belong to another edition of this title.
Book Description Hardcover. Condition: New. HARDCOVER Book, New Condition, Fast Shipping. Ready in Stock. 4th Edition. [Please Read Carefully Before Buying], This Is An International Edition. Printed In Black and White. 304 Pages, Book Cover And ISBN No May Be Different From US Edition. Restricted Sales Disclaimer Wordings Not For Sales In USA And Canada May Be Printed On The Cover Of The Book. Standard Shipping 7-14 Business Days. Expedited Shiping 4-8 Business Days. ***WE DO NOT ENTERTAIN BULK ORDERS.*** The Books May Be Ship From Overseas For Inventory Purpose. Seller Inventory # 473583
Book Description Hardcover. Condition: New. New, HARDCOVER International Edition, Printed in Black and White, Different ISBN, Same Content As US edition, Book Cover may be Different, in English Language. Seller Inventory # 30101
Book Description Condition: Brand New. Brand New Original US Edition, Perfect Condition. Printed in English. Excellent Quality, Service and customer satisfaction guaranteed!. Seller Inventory # AIND-86275
Book Description Condition: New. New. US edition. Perfect condition. Customer satisfaction our priority. Seller Inventory # ABE-FEB-3964
Book Description Condition: Brand New. New. US edition. Customer Satisfaction guaranteed!!. Seller Inventory # SHUB3964
Book Description Condition: New. Brand New Original US Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery.This item may ship fro the US or other locations in India depending on your location and availability. Seller Inventory # AUSBNEW-86275
Book Description Condition: Brand New. New, US edition. Excellent Customer Service. Seller Inventory # ABEUSA-3964
Book Description CBS Publishers & Distributors Pvt. Ltd., 2007. Hardcover. Condition: New. 4th edition. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments. With people living longer and longer, Dementia is now at the forefront of medical research. In answer to this changing trend, Informa Health Care and Dr. Scharre present "Long-Term Management of Dementia. "A stand-alone resource for diagnoses treatment and management issues for the patient suffering from dementia. Neurologists, psychiatrists, geriatricians, as well as secondary caregivers, including nurses and social workers, will find," Long-Term Management of Dementia" a perfect fit for health care professionals requiring a more in-depth look at this debilitating disease. Printed Pages: 285. Seller Inventory # 31377
Book Description CRC Press 2007-01-19, 2007. Hardcover. Condition: New. 4. 0849375835. Seller Inventory # 693827
Book Description Taylor & Francis Group. Condition: New. pp. 304. Seller Inventory # 7444355