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Auditing and Validation Services for FDA Regulated Industry

 

GXP Validation Consulting and Training for Process, Equipment & Software

US FDA - WHO - EMeA - DEA - GMP - GLP - GCP - Part 11 - Validation - GXP Training - Remediation
 

The Validation Group, Inc. (TVG) has extensive experience within the FDA regulated industries working under the various standards (cGMP, cGCP, cGLP, Systems) with one goal, to provide reliable Validation Consulting, Training, and Quality Assurance services that efficiently provide the assistance needed to help our clients succeed.

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Process - Equipment - Software/Systems

 

Drug - Medical Device - Biologics - Laboratory - Part 11 - Validation - Food - Nutraceutical

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! 

Turn Key 3-day On-Site GMP/API, Mock FDA or Systems Audits

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GMP Boot Camp!
 


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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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