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GMP Publications, Inc.

Food & Drug Administration (FDA)
 U.S. FDA Code of Federal Regulations & EU ICH Handbooks
Tel: 856-810-7331  Fax: 856-810-7339    sales@gmppublications.com 

All U.S. FDA CFR handbooks updated as of April 1st. 2010 - NOW SHIPPING!
CFR Rule Changes by GXPNews

Just Released July 8, 2010 Federal Register: FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs 

Pick up your copy of the Part 11 Electronic Systems Master Handbook! - GXP Academy for On-Site Part 11 Training $6,995 (2 Day all Inclusive!) 866-GXPNews

21 CFR Part 820 - Medical Device handbooks - More
Don't forget - You can mix and match parts!  Call for a free quote today! 856-810-7331
21 CFR Part 820 Quality Systems Regulations $3.95 more

Part 820 and Part 11 Electronic Systems $5.95  more...

Part 820 with 210/211 Drug GMPs and Part 11 $6.90   more...

Part 820 with Part 58 GLP   more...

Chinese Part 820 with US Part 820   more...

Part 820 with Parts 11 and 58 GLP  more...

Part 801 Labeling

Part 803 Medical Device Reporting

Part 806 Medical Devices; Reports of Corrections and Removal

Part 807 Estab. Reg. and Device Listing for Manuf. and Initial Importers...

Part 809 In-Vitro Diagnostic Products

Part 810 Medical Device Recall Authority

Part 812 Investigational Device Exemptions

Part 814 Premarket Approval of Medical Device

 

 

 

 

 
 
 

Other Medical Device handbooks in various combinations...
 
Standard Medical Device Combination Handbook -
                   21 CFR Parts 11, 50, 54, 56, 807, 812, 814, 820, PMA & 510k

 

Parts 11 & 820 along with EU Directive 93/42/EEC.

 

QSIT Manual with Part 820   Details

QSIT Manual with Parts 11 & 820

QSIT Manual with Parts 11, 803, 806, 820 & 821  $9.90

 

Medical Device Quality Systems Manuals
 530+ pages of compliance quality initiatives for all companies operating under US GMP requirements...     More Details

  Manual with Parts 820 & Auditor's Check List

  Manual with Parts 11, 210/211, 820 & Auditor's Check List

Custom Med. Dev. Combo. Handbook 5 - 21 CFR Parts 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 820, PMA & 510k Guidance Document,  Canadian Medical Device Regulations, EU Medical Device Directive & Inspection of Medical Device Manufacturers 7382.845 - $29.95 each

 

 

 
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GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com
Copyright©1998 - 2010 GMP Publications, Inc., FDA.COM and GXPNews
For technical assistance contact John Cuspilich, RA/QA GMP Publications, For sales & Marketing contact Michael Van Horn.
GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com