New FDA Laboratory Manual Available on CD-ROM
Not published in more than a decade, the new FDA Laboratory Manual on CD-ROM contains over twenty-two sections covering the latest FDA regulatory policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and court testimony. The manual is now available from the National Technical Information Service.
This new Laboratory Manual is a significant update and revision of the August 29, 1989 Laboratory Procedures Manual. The Manual is expanded to include laboratory quality objectives for ISO 17025 accreditation, additional training modules, and new sections to address measurement traceability, statistics, analysts on inspection, environmental health and safety. Two volumes are dedicated to historical guidance documents and useful websites for master lists of laboratory Quality Management Systems.
The other laboratory operations sections include environmental health and safety, handling of samples and chain of custody, completing analyst’s worksheet, basic statistics and presentation, analysts on inspection, research, private laboratory guidance, and courtroom testimony.
The training modules sections include laboratory orientation, microbiology, drug analysis, microanalytical & filth, analysis, pesticides analysis, elemental analysis, mycotoxin analysis, sensory analysis, seafood chemistry, food standards & additives, nutrient analysis, engineering and consumer complaints/product tampering.
The Laboratory Manual provides a central authoritative source for the approved and mandatory laboratory procedures, policies, fitness-for-use-criteria, and quality assurance practices to be used by Office of Regulatory Affairs scientists in the course of their daily regulatory work. This manual is the result of a cooperative effort between the FDA field laboratory staff and FDA headquarters personnel.
The FDA Laboratory Manual on CD-ROM is available from NTIS, call 1-800-553-6847 or (703) 605-6000, for $100 plus $5 handling fee, no additional charge for shipping; quote order number PB2005-591561KTE. Most major credit cards accepted. Fax orders to (703) 605-6900. Order online at http://www.ntis.gov/products/fdalab.asp .
Access information on more than 600,000 government information products on the NTIS Web site: http://www.ntis.gov .
The National Technical Information Service is the federal government’s central source for the sale of scientific, technical, engineering, and related business information produced by or for the U.S. government and complementary material from international sources. NTIS also offers thousands of multimedia, training, and educational programs produced by federal agencies. Approximately 3 million products are available from NTIS in a variety of formats: electronic download, online access, computer products, multimedia, microfiche and paper.
