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Auditing and Validation Services for FDA Regulated Industry

 
 
 

 

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GXP Compliance Audits - Remediation - Validation - Training
Tel: 001-856-596-2333 info@auditing.com
The Auditing Group, Inc. (TAG) - Provides extensive Auditing, Training and Remediation services supporting FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Auditing, Remediation, Validation, Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed. Our Scope of Audit Objectives
US FDA - WHO - EMeA - GMP - GLP - GCP

Pharmaceutical - Medical Device - Clinical - Laboratory - Part 11 - Food - Dietary Supplement

 

Not sure if your company can pass
a GMP, GLP, GCP, Quality Systems, - Part 11 & QSR Part 820 audit? 
Get an independent assessment of your quality and regulatory readiness today! 

 

Basic Training - US

Turn-Key GMP Training Includes:

  • 10 Binders and 10 Handbooks
  • Attendee Certificates of Training
  • Travel, Hotels and Expenses

This 1 Day On-Site Training Session walks the Attendees through the Basics of the US GMPs satisfying GMP Requirements for Internal Training.

Explores the basic requirement along with specific important statutes within the Regulations, for...

  • Electronic Systems - Part 11
  • Drug - 21 CFR Parts 210/211
  • Dietary Supplements - 21 CFR Part 111
  • Medical Device - 21 CFR Part 820
  • Cosmetic under 21 CFR Parts 701

Includes Predicate Rules under Part 11

 
  >> Auditing Services   >> Remediation Services

GMP, GCP, GLP, QS and Part 11 / Systems Audits

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

Food and Supplement GMP Audits

Mock FDA - EMEA Audits

Pre-Site Inspections - 'For-Cause'

Quality Assurance Audits

Quality System Audits - Part 820

SOPs, Quality Assurance and Standards Audits

GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

Software / Systems Validation Audits

Part 11 / Annex 11 Compliance

Vendor & Supplier Audits -

CMOs, Laboratories, API Manufacturers

CROs, Investigators, Monitors, and Study Sites

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

Project Management and Support Services

Gantt and Timeline Development

Validation Development and Executions

Training Services

Template Implementation

Procedures and Practice Challenges

Standard Operating Procedures Development

Development Part 11 Initiatives

Design / Build Engineering Services

Certified AIA 'As-Built' Drafting Services

Process and Equipment Validation Services

Software and Systems Validation Services

Design / Build Engineering Services
 

 

GMP Publications

GXP News for the Regulated Industry Whats new with the FDAGXP Academy
GXP Recruiters - Recruiters for the BioPharmaceutical Industry

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