Glossary
Training
Also writtenGMP training
Instructing staff so they can perform their duties and GMP, and verifying and recording its effect, both on hiring and continuously thereafter.
Source · 21 CFR 211.25 Personnel qualifications; EU GMP Part I Chapter 2 §§2.10–2.13
Details
Training is one of the combination of education, training, and experience by which 21 CFR 211.25(a) requires each employee to be enabled to perform their assigned functions; it must be given by qualified individuals on a continuing basis and with sufficient frequency, covering the particular operations and the cGMP regulations and written procedures relevant to the function, and (c) requires an adequate number of qualified personnel. EU GMP Chapter 2 §§2.10–2.11 require training for all personnel entering production, storage, and laboratory areas (including technical, maintenance, and cleaning staff) and for anyone whose activities could affect quality, require new personnel to receive job specific training beyond the basic theory and practice, require continuing training thereafter with its practical effectiveness periodically assessed, and require records to be kept; §2.12 requires special training for personnel working in clean areas or handling highly active, toxic, or sensitising materials, and §2.13 requires visitors and untrained persons to be given information beforehand and closely supervised. If the job description settles what a person is responsible for, training records prove they can do it. Inspections cite missing training records or records with a signature but no content or assessment, work performed after a procedure was revised without retraining, no assessment of training effectiveness, and trainers whose own qualification is not evidenced.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your responses to Observation 3B also state that material sanitization was the primary topic during your (b)(4) CGMP training.
FDA · FDA Warning Letter · 2023-05-30 -
Your response states that staff have been counseled and refresher training on proper aseptic technique would be completed, but no documentation related to this was provided.
FDA · FDA Warning Letter · 2021-11-16 -
In response to Observation 2 of the Form FDA 483, you stated that you provided on-site training to staff.
FDA · FDA Warning Letter · 2023-01-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
21 CFR 211.25 Personnel qualifications; EU GMP Part I Chapter 2 §§2.10–2.13GRM Regulatory Glossary
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