With the recent increase of job knowledge deficiencies being cited in regulatory inspections – especially in the areas of data integrity and sterile product manufacturing – training and qualification of personnel is becoming increasingly important to inspectors.
Additionally, agency inspectors are now asking very different – and much more advanced – questions about training, rather than simple questions like “Can you provide me a record that shows this individual was trained on this SOP?” Topics such as instructional design, control of training materials, qualification of trainers, training requirements and competency assessments are common in discussions with inspectors…and are being cited in 483s and warning letters with alarming regularity.
Is your training system up to the challenge? Join us for our 90-minute interactive training course, where you will:
- Learn to define and understand the regulatory expectations around training and training systems
- Identify the required elements of an effective training system – and whether you have them
- Receive an analysis of recent 483 and warning letter observations, and how having an effective training system would have addressed these issues before they became observations
- Learn to assess your own training system: Identify gaps that could lead to inspectional observations