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Book 9:  Regulations/Guidance on Good Laboratory Practice and Nonclinical Research

Book 9: Regulations/Guidance on Good Laboratory Practice and Nonclinical Research

$ 15.95

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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:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

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

• NEW FOR 2015: US Animal Welfare Act

• CFR Title 21:  Food and Drugs (As of April 1, 2015)
        Parts  11    Electronic Records/Electronic Signatures
                          (Revised 2015)
                  58    Good Laboratory Practice for Nonclinical Laboratory
                          Studies

• CFR Title 9:  Animals and Animal Products
   (As of April 1, 2015)
        Parts    1    Definition of Terms
                    2    Regulations (Revised 2015)
                    3    Standards
                    4    Rules of Practice Governing Procedures under the
                          Animal Welfare Act
                        

• CFR Title 29:  Labor (As of April 1, 2015)
       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