cGMP-309: FDA Inspections-PPT Format

cGMP-309: FDA Inspections Training Program Customization Available
  • Item #: 120180

This module presents how to prepare for and participate in an FDA Inspection. The objective of the module is to have your personnel prepared for a surprise FDA inspection. Specific topics presented are:

  1. Quality systems inspection techniques
  2. Checklist Preparation
  3. The inspection process
  4. Interacting with the FDA
  5. Roles and responsibilities of facility personnel
  6. Legal consequences
  7. Warning letters
  8. Recalls
  9. Seizure; voluntary hold or embargo
  10.   Injunction
  11.   Consent Decree
  12.   Debarment
  13.   Disgorgement
  14.   Prison
  15.   Fines

 PowerPoint Presentation provided electronically.  You can customize any portion of the materials.  You can replace pictures, change text, customize backgrounds, change the quiz, change the student handouts, change the course evaluation sheets, and even change the signature form. 

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Price $675.00