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
Product Details

  • 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

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