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FDA, EU, ISO, Vendors & Supplier GMP QMS Audits,
Gap Analysis, Training & Remediation Services

Mock FDA - PAI - Supplier Audits

Remediation & Gap Analysis:

  • 483 Help!  EIR 483 and Warning Letters - Compliance

  • Gap Analysis Support & Turn-Key GMP / Turn-Key GMP​​

  • Standard Operating Procedure Turn-key Development

  • Validation Audits / Writing - Process & Equipment

  • Remediation, Validation & Gap Analysis Report

  • As-Built Drawing Qualifications & Validation

  • Engineering GMP Evaluation & Analysis Services

  • DEA Controls - Facility Qualifications

  • Facility & Site Qualification Services - BOD Development

  • Factory Capability & Capacity Audits (FCCA)​

FDA 483 and Warning Letter SME Assistance
GMP, GLP, GCP and QMS Audit and Auditing Remediation
Retail Good Manufacturing Practice GMP Certificate Program
Supplier GMP Certificate Program for the Retail Market

  • Dietary Supplements & Vitamins

  • Cosmetics & Topicals

  • Protein & Nutrient Bars and Drinks

GMP Certificates supporting your Product Quality & GMP Compliance!

U.S. Based FDA / ISO Audit & Training Company Seeking Partners & Investors

GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group

FDA.COM

Food & Drug Association

Resources for Industry & Consumers

GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group

List of Common Procedures 

GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
Food and Drug Assistance, Food and Drug Association, FDA
GMP Publications, FDA, EU, Chinese CFR Handbooks and Training
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Medical Device GMPs and Combination Devices
CAPA Manager and CAPA Management
GMP Boot Camps, GMP Training, GMP Webinars
FDA 483 and Warning Letters Support and Remediation Services
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, Good Clinical Practice, The Auditing Group
The Validation Group, IQOQ, Validations.com
GMP Dietary Supplements and GMP Food
Cosmetic GMP, Cosmetic Regulations
GMP Engineering, GMP, GLP, GCP and QMS Audit and Auditing Remediation
GXP News and Announcements for FDA CFR
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, The Quality Groups, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
FDA Food and Drug Association Food and Drug Assistance
The Validation Group
FDA TV and Cabel News Channel
Good Clinical Practice GCP
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GMP Boot Camps, GMP Training, GMP Webinars

Join The Quality Groups & Expand Your Exposure!

Business Development Partners Wanted - Join our Team.
www.thequalitygroups.com    www.auditing.com   www.fda.com   www.fda.tv
GxP Audits

 

 

All Subject Matter Experts (SMEs) have the Experience, Training, Education and Background to support your compliance audit and remediation requirements backed by TAG, ASQ and Global Accepted Certifications!

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  • GMP Audits - API/Excipients

  • GLP Audits - QC, Testing and LIMs, 

  • Mock FDA/EMA, PAI, Pre-ISO

  • Vendors, Suppliers and Contractors

  • Pharmaceuticals / Supplements

  • Medical Devices / IVDs

  • Cosmetics

  • Biologics, Blood, Cell, Tissue

  • Validation Audits

  • Engineering Audits

  • Document Audits

  • Clinical Audits

  • Investigator Sites

  • Clinical Data Management

  • Clinical Electronic Systems

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GMP, GLP, GCP and QMS Audit and Auditing Remediation
Remediation

 

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The Auditing Group SMEs have the Experience to assist with your remediation efforts, whether satisfying a 'For-Cause' US FDA 483, Agency Warning Letter, or audit observations, we have the resources and tools to assist with your successful compliance endeavors.

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  • Project Management

  • CAPA Management

  • Procedure Development

  • Protocol Development

  • Design / Build Engineering Analysis

  • As-Built Qualifications

  • Commissioning and Qualifications

  • Validation Services

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Turn-key or Hourly SME Quotes!

Gantt Driven Project Management

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GMP Engineering, GMP, GLP, GCP and QMS Audit and Auditing Remediation
CAPA Manager, Remediation and GMP Audit, Auditing and Remediation
Training

 

 

                            The Auditing Group has                                    teamed up with GMP Boot                                Camps to provide on-site or                              Virtual training for your                                      Employees to satisfy your                                GxP requirements.

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  • Basic 1, 2, or 3-day GMP / QMS for Drug, Medical Device, Cosmetics or Dietary Supplements Training

  • Focused Training Programs - Taylored to your Company's Products, Services or Capabilities - Includes an on-site pre-training Audit of your GXP Compliance for training applicability.

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GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training
GMP Publications, FDA, EU, Chinese CFR Handbooks and Training
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group

The Quality Groups

Seeking Partners, Acquisitions & Investors

Contact:  partners@auditing.com

GMP Publications Regulation Handbooks
The Auditing Group GMP, GLP, and ISO Auditing, Training and Remediation Services
FDA.Com The Food and Drug Assistance Association
GMP Supplies and GMP Suppliers
GXP GMP Recruiters
GMP Suppliers and GMP Supplies
GXP Academy and GMP Boot Camps
GXP Academy and GMP Boot Camps
CAPA Manager, CAPA Management, FDA Help, Turnkey QMS, Turnkey GMP
Retail GMP Certifications
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, GMP Distributors, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group

Contact:  partners@auditing.com

GMP Packaging, GMP Warehouse, GMP Laboratory, GMP Manufacturing, The Quality Groups, GMP Publications, The Auditing Group
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