The 2016 CFR/ICH GCP Reference Guide provides the critical information you need to know to stay current with the pharmaceutical industry’s codes and regulations.
The compact nature of the guide offers an easy way to keep key device regulations right at your fingertips and readily available for quick reference. Updated as of April 1, 2016, regulations included are:
- FDA Code of Federal Regulations, Good Clinical Practice Parts 11, 50, 54, 56, 312, & 314
- ICH Guidelines Good Clinical Practice (E6) and Clinical Safety Data Management (E2A)
The convenient and easy-to-reference pocket guide is ideal for new hire packets, giveaways, IRBs, regulatory personnel, QA/QC departments, institutions, site and management organizations, CRAs, sponsors, investigator meetings, research facilities, universities, hospitals, and more!
Updates to this year’s CFRs includes clarifications in Part 11.1 regarding electronic records establishment and maintenance.
Custom Covers and Multiple Copy Discounts Available!
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Standard orders of 100+ books are only $10.95 per book!
This Guide can also be customized with your company logo for orders of 100+ books. Call for details.
4'x7' spiral bound soft cover pocket guide.
Spiral binding also available.
Device-Specific CFR Guide also available.