A clear and concise manual on how to run a quality control testing laboratory efficiently and in compliance. Hundreds of tips and techniques help the reader focus on the essential elements of good laboratory management. This book includes thirty-nine useful SOPs that have evolved from the author's years of practical experience. Fifteen case studies describe typical laboratory problems and offer solutions to them. From how to train analysts, to how to lay out the laboratory, to how to assure that samples are processed in a systematic manner, Managing the Analytical Laboratory: Plain and Simple covers it all.
o Flow of Work
o What's Wrong with My Lab?
o About SOPs
o Efficiency & Safety: Self-Contained Paperwork System; Task Oriented Workload; Support Systems; Work-Hour Matching; Safety
o Capabilities & Training
o Lab Geography & Technology
o QA: QA for the Lab; Auditing
o Lab Performance & Integrity
o Education & Education Documentation
o People, Places, & Things
o Is Your Lab Ready for an FDA Inspection?
o Case Studies
o FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories