This spiral-bound, 5" x 7.5" book is a compilation of various FDA regulations and guidance documents dealing with the conduct of nonclinical laboratory research and Good Laboratory Practice. It includes such topics as:
• 21 CFR Part 58: Good Laboratory Practice
• Care and Handling of Laboratory Animals
• OSHA Regulations on handling of hazaradous laboratory chemicals
• Part 11: Electronic Records and Signatures
Who Uses this Book?
• Anyone involved in conducting, overseeing or supporting laboratory
research whose role requires compliance with Good Laboratory
Practice, OSHA regulations and/or the Animal Welfare Act.
• Training departments, as handouts
• Human Resources, as part of new-employee orientation
What's the Price?
• 1-249 copies: $17.95 • 250-499 copies: $16.95
• 500-749 copies: $15.95 • 750+ copies: $14.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• US Animal Welfare Act
• CFR Title 21: Food and Drugs (As of April 1, 2023)
Parts 11 Electronic Records/Electronic Signatures
58 Good Laboratory Practice for Nonclinical Laboratory
Studies
• CFR Title 9: Animals and Animal Products (As of April 1, 2023)
Parts 1 Definition of Terms
2 Regulations
3 Standards
4 Rules of Practice Governing Procedures under the
Animal Welfare Act
• CFR Title 29: Labor (As of April 1, 2023)
Part 1910 Occupational Safety & Health Standards (OSHA)
Section1450: Occupational Exposure to Hazardous
Chemicals in Laboratories
• FDA Guidance for Industry
• Questions and Answers on Good Laboratory Practice
• Monitoring Good Laboratory Practice: Compliance Manual
for FDA Staff (#7348.808)
Click here to see an enlarged pdf cover