FDA-Survival-Kit

Validation can be a daunting undertaking! Our Validation Survival Kit makes it manageable.

BE PREPARED FOR YOUR NEXT VALIDATION PROJECT

The value of this package is over $2,700 - Now available for only $1097!

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Here's what you get in the kit:

  • Four-hour seminar (on CD or MP3) conducted by Gamal Amer, Ph.D. Click here to read the full description of the four one-hour segments and Dr. Amer's qualifications.
  • Handouts for the seminar (over 125 slides)
  • Checklist for Process Validation
  • Computer Documentation Collection Checklist
  • Deviation Resolution Decision Tree
  • Documentation Storage and Retrieval System (Tracking System)
  • Documentation Tracking Pages
  • Equipment Documentation Collection Checklist
  • Validation FAQs
  • Guidelines for Process Validation
  • Guidelines for SUPAC (Scale-up and Post Approval Changes)
  • Installation Qualification Template (IQ)
  • Operation Qualification Template (OQ)
  • Performance Qualification Template (PQ)
  • SOP Template
  • SOP Equipment Template
  • Validation Master Plan Template (VMP)
  • Where and How to Find Information for Establishing Protocol Acceptance Criteria
  • Guide to Selecting and Engaging the Services of a Validation Consultant

Questions about this new and exciting product? Call us at 714-289-1233.