Time: 01:00 PM EDT
Duration: 90 minutes
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.The CFR – Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated…”That being said Human Error is NOT a root cause.
Areas Covered in the Session:
• Human Error as the Root Cause
• What is Human Error
• How is Human Error controlled?
• Root Cause Determination
• Types of error
• Human error and training: when and where