304 Pages
1 B/W Illustrations
by
CRC Press
304 Pages
by
CRC Press
Also available as eBook on:
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... Read more
Historical Perspective. FDA/GLP Regulations. Applying 21 CFR Part 11 to the Laboratory Environment. The Good Automated Laboratory Practices. Implementing GLPs in a Non-GLP Analytical Laboratory. Controlling the GLP Inspection Process. Computer Systems Validation. GLP Documentation. The FDA’s GLP Inspection Program. The Future of Good Laboratory Practice Regulations
Biography
Sandy Weinberg
“…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)
