September 26, 2018   
Gillette Stadium

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Risk Management in Practice: 10 Lessons from the Trenches

1:30 PM – 2:30 PM |

Ten lessons learned while fitting the words of the Risk Management guidances into the real world of pharmaceutical processes and projects. The industry has more than a decade of experience with the Risk Management guidances.  They were written with an eye to focusing the limited budget of time, money and attention to the things that are most likely to effect pharmaceutical quality.  But there have been many challenges in using the guidances effectively and in keeping the focus on the most risky things that may effect quality.  This discussion will cover ten lessons from the trenches of process validation and project execution and qualification, and what we can learn from those lessons, to develop more effective Risk Management approaches.

Three take away points

  • Risk Management requires creative and thoughtful engineering
  • Risk Management is a potentially powerful tool to save time, energy and money without sacrificing quality
  • Risk Management as practiced is filled with potential landmines for the unaware

Speaker: David MacDonald | Principal Engineer, Hyde Engineering

Dave Macdonald is a Principal Engineer at Hyde Engineering + Consulting, working on front-end engineering, project owners representative and the commissioning and qualification of both small and large molecule capital projects. He has seventeen years of experience in the pharma/biotech industry including leadership roles in process engineering, project engineering, chemical development and commercial launch with operating companies. He has worked at Agilent Technologies, Avecia Biotechnology, Zenenca, and Ciba. He is a past member of the ISPE Boston Board of directors and the Educational Programs Committee.