Phyllis Fender

Phyllis Fender

Company: Carestream Health

Job title: Senior Validation Manager, Regulatory Affairs & Quality Systems

Seminars:

Chair’s Opening Remarks 9:20 am

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day: Day One

Effectively Introducing a Global Implementation of a SaaS Based Solution Using a CSA Approach 10:00 am

How to perform a major technology transformation while utilizing an unproven CSA Approach in a risk-adverse company Overcoming obstacles with technology differences, user adoption, and management uncertainty Operationalization of CSA approach and maintaining compliance long-termRead more

day: Day One

Chair’s Closing Remarks & End of Conference Day 1 4:00 pm

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day: Day One

Panel Discussion: How Can You Leverage CSA to Ensure Compliance and Reduce Documentation? 11:30 am

Overcoming the challenges CSA guidelines pose by frontloading effort into more extensive risk assessments What work is required to properly implement a CSA approach, including cloud IQ/OQ certificates from cloud service providers? How do you leverage vendor testing in an organization’s authoring of a PQ?Read more

day: Day One

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