Connected, integrated, compliant. Build, scale, and optimize your quality and regulatory workflows with SmartSolve®, IQVIA's transformative Enterprise Quality Management System, built for Life Sciences.
Employees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Risk-based employee training is essential to bridging the awareness gap.
Since the adoption of ISO 13485:2016, life sciences manufacturers have continued to step up their risk-based training requirements. How does your organization currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process.
For life sciences manufacturers, the product design and the development of the manufacturing process will yield critical steps that need to be defined because they impact the quality of the process and/or the safety and performance of the product.
Determining Training Requirements
When determining the training requirements for these process steps, you will benefit from analyzing:
Training requirements and effectiveness checks should be proportionate to the risk associated with the work.
Does your business associate the risk for both role-level training and for job-specific requirements?
The answer would be “it depends.” If someone has the role of a “Qualified Person,” who is signing off on a batch release, or if a Quality Manager is signing off as a CAPA approver, these roles have a risk associated with their job activities.
How is that risk accounted for in the respective training requirements?
A specific lab test that a lab technician needs to run for a product may have a unique risk depending on the specific product and/or process criticality; therefore, a specific training document or lab procedure may be linked to a critical characteristic that has a specific risk value.
Finally, how will your organization capture this information and link it to objective evidence required for the competency of each role and/or requirement? Consider seeking a training management system that includes data capture capabilities and dashboards to provide you enterprise-wide visibility into training gaps, completion, and history.
Risk-based quality processes and training requirements are key elements within ISO 13485:2016. So, how can you keep both new and long-time employees up to date on product liability issues and make sure they understand that risk management and regulatory compliance are everyone’s responsibility? If you don’t have a plan for this, now is the time to act.
Adopt an automated training management system along with other internal continuing education efforts to ensure a skilled and compliant workforce, enabling you to increase productivity, reduce job quality issues, and maintain compliance with industry regulations. SmartSolve® QMS from IQVIA contains out-of-the-box best practices for:
Connected, integrated, compliant. Build, scale, and optimize your quality and regulatory workflows with SmartSolve®, IQVIA's transformative Enterprise Quality Management System, built for Life Sciences.
IQVIA RIM Smart. Intelligence, automation and integration.
Discover how AI and ML reduce risk and increase efficiency in adverse event reporting
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.
IQVIA Vigilance Platform is our secure SaaS environment built to simplify safety and PV processes, while boosting speed, accuracy, and efficiency.
Harness the power of automation to execute streamlined end-to-end safety solutions while reducing costs.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.