Need Turn-key Procedures, Manuals and Validation Protocols Templates?

The Auditing Group
A division of
The GMP Quality Groups

GMP Publications, FDA, EU, Chinese CFR Handbooks and Training

GMP GXP Quality Audit Services:

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

GMP Audits - Drugs, APIs, Excipients & DEA
Medical Device - QMS/QSR Audits - Part 820 QSR / ISO 13485
Vendor - Supplier Audits, CMOs, CDMOs, CAO, CRO, CPO
Dietary Supplements & Food GMP Certificate Programs
Laboratory Audits - GLP/GCLP - Part 58/OECD
21 CFR Part 11 Systems & Software Compliance Audits
Cosmetics & Healthcare Product Manufacturing
Company Acquisitions & Compliance Audits
Mock FDA, EU, NMPA & WHO Audits
Clinical Audits, CROs, GCLP, Investigator Sites
Retail Market Supplier GMP Certificates
Combination Devices, MDSAP Audits, 21 CFR Part 4 Support
Validation Audits - Process, Equipment, 21 CFR Part 11.10(a), Facilities

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
503b Outsourced GMP Facility Qualifications
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!

More Info...

FDA.COM

Food & Drug Association

Resources for Industry & Consumers

Procedures & Templates

List of Common Procedures

Food and Drug Assistance, Food and Drug Association, FDA

Audits GMP, GLP, GCP and QMS Audit and Audit Remediation. Vendors, Suppliers, and FDA Mock Audits

GMP Boot Camps, GMP, QMS , FDA, Webinars and onsite Training

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

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!

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

More Info

Remediation

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.

Project Management
CAPA Management
Procedure Development
Protocol Development
Design / Build Engineering Analysis
As-Built Qualifications
Commissioning and Qualifications
Validation Services

Turn-key or Hourly SME Quotes!

Gantt Driven Project Management

More Info

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.

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.