Kate Coleman

Director/Senior Consultant Quality and Compliance at PharmaLex

Kate is a Quality professional with 18 years experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, High Potency oncology and Solid Oral Dose products. Kate is an SME in Quality Risk Management and works with her clients to deliver and remediate QRM programs providing efficiency and clarity across the product lifecycle

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Title: Implementation of an efficient QRM program

Quality Risk Management has been a hot topic for many years in the Pharmaceutical Industry and appropriate management of risk in our processes and procedures has become the foundation on which Quality compliance is based. However, QRM programs often become complex and unwieldy with exponential growth in the number of Risk Assessments and often the true value and benefit of a QRM program is not realised. This presentation will discuss how to get the most benefit from a QRM program so that it delivers its full potential as a powerful tool for decision making, prioritisation, efficiency, continuous improvement, training and knowledge management.

  1. What are the key elements of an efficient and useful QRM program
  2. How to implement a QRM program that demonstrates benefit to all stakeholders
  3. How to move the focus away from Risk Assessment tools to a more holistic QRM approach

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