TRAINING: Risk management for pharmaceutical companies

3,500.00

RISK-ACADEMY has developed a risk management course specifically designed for pharmaceutical companies. The course is based on the risk management recommendations made by cGMP, ICH Q8, ICH Q9, ICH Q10, ISO 14971:2000, ISO 9001:2015 and ISO 31000:2010. It is based on the latest research in the field of risk -based decision making and risk perception created by G31000, British Institute of Risk Management, as well as RISK-ACADEMY’s own analysis.

Description

RISK-ACADEMY has developed a risk management course specifically designed for pharmaceutical companies. The course is based on the risk management recommendations made by cGMP, ICH Q8, ICH Q9, ICH Q10, ISO 14971:2000, ISO 9001:2015 and ISO 31000:2010. It is based on the latest research in the field of risk -based decision making and risk perception created by G31000, British Institute of Risk Management, as well as RISK-ACADEMY’s own analysis.

Over the past two years, more than 1000 business owners and managers have taken courses developed by RISK-ACADEMY. Past clients include Gazprom, Russian Railways, Severstal, RUSNANO, GazpromNeft, SKOLKOVO, Lukoil Overseas and dozens of others. We have also provided training for graduate and postgraduate students at Moscow International Higher Business School (MIRBIS), Open University Skolkovo, Moscow Higher School of Economics, Moscow University of Finance and Law, and Uralo-Siberian Institute of Business.

All of our courses involve wide-ranging practical case studies and exercises. We develop individual case studies and practical examples upon request. We offer training sessions in Russian and English.

Course Program

I. INTRODUCTION TO RISK MANAGEMENT

  • Definition of “risk”
  • Standards and requirements in risk management for pharmaceutical companies (cGMP, ICH Q8, ICH Q9, ICH Q10, ISO 14971:2000, ISO 9001:2015, ISO 31000:2010)
  • Integrating risk management into drug development, clinical trials, validation, production and testing.
II. RISK MANAGEMENT PSYCHOLOGY 

  • Cognitive biases and risk perception in risk management
  • Building risk management culture
III. RISK MANAGEMENT IN QUALITY CONTROL

  • Risk analysis tools for different stages of the drug development lifecycle (FTA, HAZOP, HACCP, FMEA, FMECA, PHA)
  • Risk mitigation tools
  • Monitoring, records keeping and submitting to regulators

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