Handbooks >Drug GMPMedical DeviceClinical - LaboratoryBiologic-Blood-TissueCosmetic-Food-DietaryElectronic SystemsEU - ICH - Misc.More...



Auditing and Validation Services for FDA Regulated Industry

 
 

 

P Aud

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

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)

2) Remediate, (with Certificate of Compliance) and,

3) Training (with Certificate of Attendance)


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

 

 

GMP Publications

GXP News for the Regulated Industry Whats new with the FDA

GXP Academy
GXP Recruiters - Recruiters for the BioPharmaceutical Industry


© 2002 - 2019 The Auditing Group, Inc., a New Jersey Corporation. All rights reserved
Home  |  Contact Us  |  Site Map

Auditing - Full Service Auditing Services