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ComplianceOnline Home > ComplianceOnline Standards > FDA Audit, Validation & Documentation – Checklist, Templates& master plans
 
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FDA Audit, Validation & Documentation: Quality & Compliance Manuals, Checklists & more - ComplianceOnline.com

FDA Audit, Validation & Documentation

ComplianceOnline is the largest resource on the web for latest checklists, templates, SOPs, master plans, procedures and application on standards and regulations across industries (FDA, SOX, ISO ,Medical Device, Pharma, Manufacturing, Construction, Environment, hitech).
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Validation Master Plan
Validation master plan for equipment hardware, computer systems, networked spreadsheet applications and legacy systems. Framework and starting point for all other validation documents.The product includes forms, checklists for quick start and implementation.
Author: Dr. Ludwig Huber
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Source: LabCompliance
Price: $90.00
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Risk Management Master Plan
Model master plan for equipment, computer systems, networks, spreadsheet applications.The product includes two SOPs, forms and checklists for quick start and implementation. Framework and starting point for individual risk management project plans.
Author: Dr. Ludwig Huber
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Source: LabCompliance
Price: $129.00
Standard Operating Procedure: FDA Inspections
Includes step-by-step procedure to make FDA and other inspections from food and heathcare agencies succesful. Includes three attachments with templates for eayy implementation.
Author: Dr. Ludwig huber
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Source: LabCompliance
Price: $49.00
Generation and maintenance of SOPs
Describes procedures for generation, distribution and maintenance of SOPs as required by the regulated healthcare industry and by organizations that should comply with quality or accreditation standards such as ISO 9000 or 17025 standards.
Author: Dr. Ludwig Huber
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Source: LabCompliance
Price: $49.00
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Qualification of Equipment
Describes procedures for equipment qualification as required by the regulated healthcare industry and by organizations that should comply with quality or accreditation standards such as ISO 9000 or 17025 standards.
Author: Dr. Ludwig Huber
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Source: LabCompliance
Price: $49.00
 
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Featured Online Training
 
  Introduction to FDA Good Documentation Practices  
Instructor: Chris Whalley
 
This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.  
  Introduction to FDA Good Documentation Practices  
Instructor: Chris Whalley
 
This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.  
  Risk Assessment-Compliance Using Easy To Fill Out Documentation  
Instructor: David Nettleton
 
Learn how to perform risk assessment as part of the risk-based approach to computer system validation.