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P Aud

GXP Compliance Audits - Remediation - Validation - Training

Tel: 001-856-437-5880 info@auditing.com Get an On-site Audit Quote Today!

GMP QMS Monthly Boot Camps



The Auditing Group, Inc. (TAG) - Provides extensive Auditing, Training and Remediation services supporting regulated industries working under 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.

  • GMP Audits - Bio-pharmaceuticals - Excipients and APIs
  • GMP Audits - Medical Device - ISO 13485 - EU 745 & 746/2017
  • GLP Audits - 21 CFR Parts 58, 210/211 and Pre-Clinical
  • 21 CFR Part 11 Electronic Systems & Software
  • Food & Dietary Supplements
  • Company Acquisitions & Risk Assessments
  • Mock FDA, PAI, EU, MNPA and WHO Audits
  • Remediation and Validation Services
  • Quality Management System (QMS) Audits (GMP)
Request a Quote Conduct a 'Due-Diligence cGMP Quality System Audit and Gap Analysis Today!

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


CAPA Manager

CAPA Manager and CAPA Management Services

Practical CAPA Solution.
We are here, Always Managing, so you do not have to!

CAPA Managers specializes in helping corporations and small businesses with all their CAPA Compliance needs. Because we are well versed in law pertaining to the Code of Federal Regulations (CFRs) pertaining to the Food and Drug Industry, we know exactly what it takes to help you in all your Compliance endeavors.


GMP Help Desk

GMP Help Desk

GMP Help Desk is a consortium of industry professionals dedicated to supporting the GMP Lifestyle.

Assisting Companies and Professionals to meet and exceed cGMP Compliance for the regulated industry.

On-line Resources, Templates and Standards to Support Global GMP Initiatives


You purchased the handbooks from GMP Publications and now what?

1. Do you have the resources to conduct proper training against the Regulations based upon applicability?

2. Have you conducted a formal Gap Analysis against the Regulations?

If not, consider TurnKey QMS and The Auditing Group, together assisting firms to meeting and exceed GMP requirements.

Do you need to?

First, Understand the FDA Thinking;

If products, or services, or any action, in whole or in part, which may impact either directly or indirectly, is distributed, adhered, affixed, consumed, or used by a Consumer or Patient, either by Use, Ingestion, Injection, Inhalation, and/or Permeation, they must follow GMPs, or…

If a product is manufactured, or services rendered which greatly benefits the safety, health or welfare of a consumer or patient, directly, and/or indirectly, or…

If a Product or Data which may influence, form a decision for, or create an adverse reactionary event to the health, safety, welfare of a Consumer or Patient, directly or indirectly;

You must comply to the GMPs!

So, what is a Product? What are Services? What are Data? What is direct and/or Indirect impact?

Your applicability to the Federal Regulations is based upon the Product, Service or Data that you provide. And the question is, what is your applicability, directly and/or indirectly?
And this is the hardest concept to understand.

The 3 Step Approach for GMP Compliance - ART

1) Audit, (with Certificate of Audit) - The Audiiting Goup

2) Remediate, (with Certificate of Compliance) - TKQMS

3) Train (with Certificate of Attendance) - GMP Boot Camps


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! 


>>  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

QMS Template Implementation

Procedure 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

 

 


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