TAL – Training & Learning Business Process
The Training & Learning (TAL) business process governs the definition, delivery, tracking, and verification of training and competency requirements to ensure personnel are qualified to perform GMP and quality-related activities.
Training & Learning Operating Model
The Training & Learning Operating Model below illustrates how training requirements are defined, delivered, completed, and verified to support compliant execution of GMP operations across all process families.
Role definitions and competency requirements
SOPs, Work Instructions, and process changes
Regulatory and quality training expectations
Role-based and risk-based training assignment
Instructor-led, electronic, or on-the-job training execution
Verification of completion and learner understanding
Maintenance of training records and qualification status
Qualified personnel
Verified training records
Role-based competency status
Training must be completed and verified prior to independent performance of GMP or quality-impacting activities. Training records serve as auditable evidence of personnel qualification.
Process Interfaces & Boundaries
- Upstream: QMS governance, process families, and regulatory requirements
- Downstream: All GMP and quality process families – execution by qualified personnel
- Governance: QMS defines training, qualification, and retraining expectations; TAL executes training controls
Quality Control Requirements Supported by Training & Learning
Training & Learning is classified as a QMS-Governed / QC-Enabling Domain. Training activities support defined Quality Control Requirements in accordance with the Quality Control Requirements Index (QC-REQ-IDX) under the authority of Quality Control Operations (QCO).
- QC-CHG-004 – Change Effectiveness Review: Training & Learning ensures personnel competency and training completion support effective implementation of process, system, and procedural changes impacting GMP activities.
Training & Learning does not establish acceptance criteria or make disposition decisions. It supports Quality Control effectiveness by maintaining competency governance and traceable training records within the QMS framework.
Training gaps, overdue qualifications, or competency concerns identified through TAL activities are documented and escalated in accordance with the enterprise Quality System.