Smarter, Faster, Better Validation
Merry Danley, Director Operational Effectiveness, Q2 Solutions
Jim Brooks, GxP Solution Owner, IDBS
Ryan McGee, Associate Director, Bioanalysis, Incyte
Dan Curtis, Cloud Validation Services, IDBS
About the Session:
What does it mean to be smarter, faster and better at computer system validation? Some examples include leveraging, not duplicating, vendor activities and applying principles of Computer Software Assurance (CSA) to apply critical thinking and eliminate unnecessary documentation. Join us for an engaging dialog between industry experts on the evolution of validation, software as a service (SaaS) considerations, and how to overcome the biggest validation challenges of today.
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Merry is currently leading an active implementation at Q2 Solutions to harmonize BioAnalytical and Vaccine processes across the various sites as well as combining platforms from lab acquisitions. Prior to joining Q2 Solutions, Merry spent 20 years in clinical laboratory informatics implementations including ELN, LIMS, eTMF, EDC, Lab Instrumentation, EDA, CTMS, QMS, Clinical Lab and data informatics. She has managed a global validation team as well as supporting global audits for 12 years supporting various platforms across the organization including ELN. This includes regulatory audits from FDA, Swiss Medic, MHRA, Chinese FDA and Canada Health specifically around Bioanalytical informatics including ELN.
Jim Brooks is the GxP Solution Owner for the IDBS Polar Platform. He is accountable for defining the processes and procedures as well as coordinating and executing the activities required to deliver qualified GxP systems and solutions to our customers. During his long-standing years in BioPharma, he was responsible for validating, deploying, and managing laboratory information systems in GxP regulated environments.
Ryan has enjoyed a +20 year career in Bioanalysis starting as a bench scientist through his current role an Associate Director in the DMPK / Clinical Pharmacology group at Incyte where he leads the Regulated Bioanalytical group. In this role, Ryan is responsible for the overall planning, execution, and quality of bioanalysis in support of preclinical toxicology through registration studies. Ryan is also responsible for the operational aspects of the group where he oversees the Sample Management team, Equipment IQ/OQ schedules, and Computer System Validation (CSV).
Prior to joining IDBS in 2016 Dan gained experience from a diverse range of industry sectors in both consultative and leadership roles. A career that has spanned 25 years in Software testing and Test Management opens many opportunities to drive change and innovate whether that be on the latest satellite control room software, search engine or e-book publishing and distribution system, requirements and regulations are constantly changing and evolving. One constant has been how to bring something new to the status quo. IDBS opened yet more new opportunities to innovate, evolving the approach to software
validation in SaaS systems. Upon devising and developing the first SaaS automated OQ this has been extended and developed into a revolutionary automated PQ, a step towards continuous validation. As Manager of Cloud Validation Services, working closely with customers, Quality and Engineering teams leveraging the automation and validation experience from previous roles Dan continues to drive change and efficiencies at IDBS.