Karen Pendergraft

Karen Pendergraft

Job title: Senior Program Manager - GxP Systems Compliance

Bio:

During her 30 year career in Life Sciences, Karen has worked with medical device, pharmaceutical, healthcare, and many other life sciences organization and has migrated more than 3,000 applications, databases, and platforms to the cloud. She is currently the Senior Program Manager for a global pharma organization that develops Alzheimer’s and MS therapies and is managing IT Compliance and Controls bringing GxP systems up to compliance to current regulatory standards. Most of the systems she supports are migrating to the cloud during the remediation process. This company is a passion for her, as her mother has been suffering with MS since Karen was a small child.

Seminars:

Ask the experts: Morning Q&A + Open Counsel 10:30 am

Let the speakers answer the questions from the audience in this open counsel.Read more

day: Day Two

Panel Discussion: Lessons Learnt from Industry – How to Establish Collaborative Partnerships with Cloud Providers 2:00 pm

Which cloud deployment models are most suitable for you based on relative risk and system requirements? How to perform cloud vendor due diligence Understanding GxP applicability based on intended use Discussing the requirements for cloud service providers vs obligation and responsibility of the cloud customerRead more

day: Day Two

How to Leverage Vendor GxP Compliance Documentation & Audits to Streamline SDLC Validation & Documentation 9:50 am

Starting with the contract! Holding vendors accountable for maintaining GxP compliance The vendor audit should be thorough, detailed, and frequent Building a risk-based approach reduces the amount of roles-based testing required to meet regulatory requirementsRead more

day: Day Two

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