How to Avoid Data Breaches and Improve Cybersecurity in Life Sciences

On-Demand Webinar

70% of life sciences companies dealt with data breaches last year alone. Learn how to improve cybersecurity beyond network defenses to ensure your company is effectively defending against threats to enterprise systems and medical devices. The responsibility for cybersecurity does not fall solely on your network firewalls but spans all layers and areas of your organization. 

The discussion will include:

  • What is required to establish a comprehensive and risk-based product SDLC (including cyber vulnerabilities).  
  • Product Security Model for portfolio-wide cybersecurity that enables companies to better address cybersecurity vulnerabilities and exploits. 
  • How to implement enterprise-wide business processes to better manage and protect your organization and its high-value information assets.
  • Live Q & A session

 

About the Presenters:

Michael Ambrose 85x105 rightMichael Ambrose is the Vice President of Laboratory and Manufacturing Services at USDM Life Sciences. Michael has over 33 years of Life Sciences industry experience, specializing in strategic IT and GxP compliance consulting (13 years in industry,19+ years as a consultant) focused on the delivery of practical and efficient IT solutions and compliance initiatives at the department, site and global level.

Michael's skills include the development and execution of strategic compliance and risk management programs, infrastructure qualification, computerized system validation, implementation of quality systems, and organizational assessments/auditing for conformance with industry best practices and regulatory requirements.

Areas of expertise include:

  • Development and execution of compliance and remediation programs
  • Quality management and auditing
  • Organizational development/coaching
  • Risk Management
  • Computer validation

Brian McCole 85x105 rightBrian McCole is the Vice President of Quality Initiatives at USDM Life Sciences. Brian is a highly experienced professional with a 25-year track record of assisting quality-regulated companies define, develop, and achieve their compliance goals. He also has experience with business process improvement, change management, medical device security, and implementing the leading governance supporting technologies deployed in the life sciences industry. 

As the acting Director, QA/Validation, for a global $4 billion medical device client, where he authored and implemented corporate standards for:

  • Product CyberSecurity Vulnerability Tracking and Mitigation (based on the FDA’s pre and post market cybersecurity guidances)
  • Product Development and Validation Process (based on IEC 62304:2015 – Medical device software process)
  • Computer systems validation (including applications, infrastructure, and GxP support technologies).   

 

 

 

 

 

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  • 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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