Overview:

The Pharmaceutical Risk Management Training Course provides individuals with the chance to investigate how important risk management has now become to the healthcare industry.

Learners will gain an understanding of the regulatory viewpoint, associated guidance and they will have the chance to apply different tools and techniques through a series of case study activities.

Content:

• Identify why Risk Management has become important in the regulatory world of healthcare manufacturing

  • Flexible regulatory approach: companies can now determine the most appropriate decisions and actions to take

• Interpret the International Conference for Harmonisation Q9/Annex 20 guidance document

  • Clarification of the EU and FDA perspective including regulatory expectations of a pharmaceutical risk management site process

• Learn how Risk Management could work for your organisation

  • Determine the success criteria for utilising Risk Management

  • Risk Management teams, roles, strong leadership, documentation and likely pitfalls

  • Understanding the subject of human error

• Consider different methods and documentation for applying Risk Management to daily operations, including HACCP, FMEA and the GAMP®  approach

  • A summary of different approaches to Risk Assessment methods and focus of use, giving examples of HACCP, FMEA and GAMP®’s approach

• Apply Risk Assessment methods to three different case study scenarios:

  • Determine critical control points in a production process using the HACCP tool

  • Determine the corrective actions needed to eliminate, mitigate or control identified hazards in a pharmaceutical manufacturing process using the FMEA tool

  • Determine the level of qualification testing required in a pharmaceutical packaging validation project using the GAMP® approach