Conference Compendium

3rd Annual Data Integrity Validation

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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