Phyllis Fender
Company: Carestream Health
Job title: Senior Validation Manager, Regulatory Affairs & Quality Systems
Seminars:
Chair’s Opening Remarks 9:20 am
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
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