Training course on Quality Risk Management (QRM)

This course will deliver an in-depth overview to risk based quality management on how to assess risk and improve quality in your organisation. As an introduction, general risk management concepts and methodologies will be presented as the basis for Quality Risk Management (QRM) in clinical development and pharmacovigilance. This is then followed by a review of applicable and meaningful metrics for clinical development and pharmacovigilance processes and how these can be best applied and what change management challenges need to be considered.

KEY TOPICS
• General risk management
• QRM: Latest update on regulations
• QRM methodologies such as Failure Mode and Effects Analysis (FMEA)
• Key Risk Indicators (KRI) and other tools
• Implementation of QRM and change management aspects
• Proactive Quality by Design (QbD) aspects

CONTINUING EDUCATION
DIA meetings and trainings are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available.