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Preparing for a Regulatory Inspection                                             next documant

 
Primary audience
 

Management, staff, operations, and technical personnel who may be directly or indirectly involved in an inspection.

 
Description
  Learn why regulatory agencies (such as the U.S. FDA and Canadian authorities) conduct GMP inspections and what they look for. Humorous scenarios illustrate the worst and best ways of talking with an inspector.
 
Materials included
 
  • Instructor's manual
  • Electronic PowerPoint presentation
  • Overhead transparencies
  • Videotape (broadcast quality, 15 min.)
  • Suggestions for assessing learning
  • Suggestions for customizing course and materials
 
Length
  60 - 90 min.
 
Price
 

$690 (add $25 for PAL format video tapes)

 
 
  • English, closed captioned
  • Spanish (video and all materials optimized for Puerto Rico)

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