|English: Training Français : Formation (Photo credit: Wikipedia)|
- 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.
- Perform an assessment of all trainers against policies and procedures applicable to trainer qualifications.
- If GMP trainers need more training, consider this highly popular workshop: GMP Trainer Certification Workshop - A Public Seminar offered by SkillsPlus International Inc.
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact