Every member of your organization should approach their work with regulatory compliance in mind. This mindset will help them identify and respond to issues proactively and at low cost, as issues can be remedied wherever they arise—before their effects become consequential.
Invest in employee training for:
- ISO 13485:2016 Certification
- EU MDR Compliance
- US FDA QSR Compliance
- MDSAP
- Risk management
- CAPA
- Internal Audits
Kapstone can help your team be prepared and competent for all of these topics and can tailor training as much as needed to be effective for your team. We’re flexible to providing training sessions as short as a half day to as long as on-going periodic touch points. We can offer coaching or mentor style opportunities best suited for your personnel.
Risk Management Training
You know that risk management is a core responsibility for medical device companies. But do you know exactly what goes into effective and efficient risk management? Is your team properly educated on how to implement your risk management strategies?
Risk management training helps your organization and its employees proactively evaluate risk in the right mindset, taking all potential hazards and risks into account.
CAPA Training
CAPA, or Corrective and Preventive Action, procedures are an important part of regulatory compliance. Under CAPA requirements, your organization is responsible for creating and maintaining procedures that:
- Analyze all data sources to identify potential nonconformities or other quality issues
- Are prepared to investigate the causes of nonconformities
- Can identify the actions needed to remedy nonconformities and prevent them from happening in the future
- Ensure that corrective action is effective and does not have any adverse effects on the function of your device
- Can implement and document corrective changes to procedure
- Clearly communicate procedural changes
- Are prepared for management-level reviews of identified problems and solutions
Effective CAPA procedures require constant input from most, if not all, of your team members. We can help you train them to recognize, report on, and remedy nonconformities.
Internal Audit Training
Regular audits are essential to ensuring that your protocols are functioning as expected and that your team is following procedures as stated in your quality system. However, audits can be quite complicated—particularly for employees who have never conducted them before, or who don’t understand your organization’s quality standards.
Internal audit training brings your employees up to speed on every part of auditing: observation, measurement, evaluation, and recommendations for improvement. Committing to excellence in your internal auditing is the best way to prepare for consequential external evaluations.
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