Training for cGMP Compliance
Training for cGMP 21 CFR 211, Section 211.25
• Each person engaged in the manufacture, processing, packing, or
holding of a drug product should have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.
• Training should be in the particular operations that employee
performs and in cGMP as they relate to employee's functions.
• Training in cGMP should be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.
Training Overview Site/Corporate Training Policies: • Who needs to be trained • Training contents • Responsibilities • Procedure
Individual Employee Training Program • Requirements • Qualification • Gaps • Plan • Conduct • Evaluation • On-going update
How to Effectively Train on Regulations? • Demonstrate the need for compliance training • Show business benefits e.g., advantage of erecords/signatures with part 11 • Show impact of non compliance • Demonstrate personal benefits e.g., enhance job opportunities
Warning Letters • Laboratory employees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations. • Failure to adequately establish procedures for identifying training needs and ensure all personnel are trained to adequately perform their assigned responsibilities and the training is documented. • Failure to document on the job training.
Want to learn more about cGMPs, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: • Current Good Manufacturing Practices • cGMPs for Medical Devices, including In Vitro Diagnostic Devices • FDA's Current Thinking for Industry cGMPs for Phase 1 INDs • GMP Compliance for Quality Control and Contract Laboratories • GMP AuditorTraining for Pharmaceutical Companies • How to Avoid GMP Non-Compliance Due to Raw Material Issues