How Risk Management Reduces FDA Audit Findings and Operational Costs

Recorded Webinar

Learn about the benefits of developing and implementing a comprehensive risk management program across all departments of your life science company, allowing for a heightened awareness of the overall compliance risk state, and an ability to review, compare and contrast otherwise heterogeneous risks using a homogeneous approach and methodology. 

The discussion will include:

  • The prevalence of "predictable surprises"
  • The lifecycle of a healthy risk management system
  • Events or circumstances that suggest heightened risk, requiring a deliberate risk management response
  • Implementing a customized Risk Management methodology; comparing and contrasting the significance of otherwise hetrogeneous risks
  • Live Q & A session

About the Presenter:

Doug Butler 3 right 85x105Doug is the Vice President of Risk Management Services and Solutions at USDM Life Sciences.  Doug is a 15+ year veteran of the pharmaceutical industry.  His current work at USDM Life Sciences involves helping life science companies evolve their risk management processes, both in line with regulatory expectations (e.g., GMP) as well as business best practices.

Prior to joining USDM, Doug was the Vice President of Audit & Assurance for GlaxoSmithKline's global R&D activities.  Other duties at GSK included leading an internal pharmacovigilance audit team, and leading a group responsible for sharing learnings and risk mitigation approaches across different therapeutic areas.  Doug has experience that spans commercial, R&D, GMP, Pharmacovigilance, HR, and Corporate functions.

His interests are in risk management and in helping companies build solutions that are right-sized for their maturity, and make a difference in how well they are managing their risks to get in front of issues before they become problems.

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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