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Aug 23, 2017 7:00 am EDT
IVT’s Data Integrity Validation conference took place August 16-17 in San Diego, CA, to provide tangible examples and gain hands-on experience for improving your processes at work. It is imperative to execute compliant practices enterprise-wide to ensure data integrity compliance today, and this was the industry's go to event to build proactive strategies to prevent and remedy data integrity non-compliance. Click here to read the agenda.
Key Topics Include:
ALCOA+ Principles
Design Controls
Inspection Preparation
Continual Gap Analysis
Regulatory Update
Laboratory Assessments
Risk-Based Approaches
Robust CAPA
Audit Trail Monitoring
Industry Thought Leaders Include:
Bradford Allen, Global GMP Computer Systems Quality, Genentech
Bob Buhlmann, Director Corporate Quality Assurance, Amgen, Inc.
Ed Eirikis, Computer validation & Compliance Manager, Janssen BioTherapeutics
Cathlin Shapiro, MBA, CISA, Associate Director, Systems Compliance and Quality Programs, Global Quality, Bristol-Myers Squibb
Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
James P. Stumpff, RPh, Principal Consultant, PAREXEL International, Former Supervisory Investigator, FDA
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