GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP Publications, Inc. 


Auditing and Validation Services for FDA Regulated Industry

 3-day on-site GMP/API Drug or Device Audit,

 2-day GMP (Drug or Device) Training,

 Audit Certificate

 Training Certificates for up to 25 Attendees

 25 Course Binders*,

 25 Master GMP Desk Reference Sets, along with

 Report, Travel, Hotels and Expenses

All Inclusive - $7,995.00**


or a 3-day on-site Audit, 20 Handbooks, Travel, Hotels and Expenses for $5,995.00


* Add $25.00 for each additional binder

**For International Audits - Call 856-810-1825 for more details


 FDA - WHO - EMeA - DEA - GMP - GLP - GCP - Part 11 - Validation - GXP Training - Remediation

GMP Publications and The Auditing Group (TAG) has teamed up to provide extensive experience within the FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable auditing, validation, consulting, training, and quality assurance services that efficiently provide the assistance needed to help our clients succeed.

At GMP Publications and The Auditing Group (TAG),  stand behind all of our audits, training services, site remediation and validation projects, even in times of ‘for-cause’.

It is our objective to become your partner in your quality initiative!

For a complete description of the Boot Camp Training for Drug Industry -

For a complete description of the Boot Camp Training for the Device Industry -



Additional Audit Services Additional GMP Training Remediation Services

GMP, GCP, GLP Audits

Quality System Audits - Part 820

21 CFR Part(s) 11, 210/211, 820, ICH Q7

Vendor & Supplier Audits -
Food and Dietary Supplement GMP Audits

Mock FDA - EMEA Audits

Pre-Site Inspections - 'For-Cause'

Quality Assurance Audits

SOPs, Quality Assurance Audits

GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

Software / Systems Validation Audits

Part 11 / Annex 11 Compliance

CMOs, Laboratories, API Manufacturers

CROs, Investigators, Monitors, and Study Sites

Database Audits, SAS, CMMS, eDC, eCFR, Safety

GMP Basics 101 & 102
GLP - Good Laboratory Practices
GCP - Good Clinical Practices 101
Good Validation Practices
21 CFR Part 11 and Systems

Project Management Services
Gantt and Timeline Development
Template Implementation
SOP Development
Development Part 11 Initiatives
Software and Systems Validation Development

Equipment Validation Development
Process Validation Development
Facilities Site Qualification Development



example: 211, ISBN, Drug, GMP, Etc. - Press Enter
End of Year Special Featured Publication GMP Boot Camp Mix and Match GCP Device GMP GCP-DRUG Featured Publication
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