Thursday, January 16, 2014

GMP Training Needs To Be Conducted By Trained & Qualified Individuals

English: Training Français : Formation
English: Training Français : Formation (Photo credit: Wikipedia)
Act now to avoid these common deficiencies:
  • Failure to ensure that each person has the education, training and experience to perform their assigned functions
  • Failure to document that all personnel are trained to adequately perform their assigned responsibilities
Food For Thought On GMP Trainers:
  • cGMP trainers should be trained and qualified instructors who have the required background and experience in the subject matter. 
  • Be aware that when “repeated” errors are noted in documents, inspectors will look at training records to see if the trainers have been trained. 
  • One documentation approach is to keep resumes of all trainers on file permanently, so that they are available for FDA inspection. 
What Now?:
Useful References:

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