ComplianceOnline
Best Practices Best Practices
Online Training Online Training
Seminar Seminar
Standards
Welcome,
Guest
Free Registration | Sign In
ComplianceOnline Home > ComplianceOnline Standards > FDA Audit, Validation & Documentation – Checklist, Templates& master plans
 
 Browse Category
 
    Aerospace
    Agriculture and Farm Machinery
    Automotive, Aircraft & Marine technology
    Banking, Corp. finance & Sox
    Biotech & Pharmaceutical Standards
    Chemical technology
    Civil engineering and construction
    Computer Hardware
    Electrical Engineering
    Electronic Equipment
    Energy and Heat Transfer Engineering
    Environment & Health protection
    FDA Audit, Validation & Documentation
    Food Technology
    GXP Compliance Tools New
    HIPAA Compliance
    Human Resource
    Industry Reports New
    ISO Published Standards
    IT and PCI Compliance
    Leather and Textile
    Manufacturing Engineering
    Medical Device and Healthcare Technology
    Metal, Mining and Minerals
    Packaging and Distribution
    Paper and Plastic Industries
    Petroleum products
    Quality Terminologies & Documentations
    Safety Engineering
    Test Methods & Procedures
    Trade Supply Chain and Logistics
 
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

Product Detail:
  • The United States Food and Drug Administration inspect pharmaceutical companies and device manufacturers to assess if controls, procedures and practices for development and manufacturing of products are in compliance with FDA regulations.
  • FDA inspections can have a high impact on a company's business success as well on a company's and individual's reputation.
  • This procedure should help make FDA and other inspections successful, which basically means avoiding inspectional observations and warning letters.
  • In case deviations are found follow-up procedures should help to minimize damage to a company

Product Scope:

Preparation, conduct and follow-up of inspections made by representatives of the United States Food and Drug Administration. The procedure is also applicable to other inspections by regulatory agencies.

Who will benefit:

  • Quality Assurance
  • Functional Supervisor (Laboratory/Manufacturing)
  • Inspection Team
  • Regulatory Affairs
  • IT
  • Validation Group
  • Management
Customer Testimonials
This product hasn't been reviewed yet.
Review this product
 
 Member Service
 
Toll Free  +1-888-717-2436
Fax  +1-650-963-2556
Email  editor@complianceonline.com
 
 Your Shopping Cart
Contains 0 items    Total: $0.00
Customers Also Bought
Compliance Matrix-1
Price: $9
 
Compliance Matrix-2
Price: $9
 
Compliance Matrix Completed
Price: $9
 
Configuration Audit
Price: $17
 
Configuration Management
Price: $97
 
Contingency Plan
Price: $37
 
Related Trainings
Implementing a Risk-Based Internal CGMP Annual Audit Program
 
’Performing effective supplier audits: a coming FDA compliance focus&rsquo...
 
’Using the FDA guidance ’General Principles of Software Validation’ to strengthe...
 
Verification vs. Validation