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Boston Convention and Exhibition Center

Jun 24, 2018 8:30 AM - Jun 28, 2018 12:00 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

FDA Warning Letters on Data Integrity

Session Chair(s)

Anu  Virkar, MA, MS, PMP

Anu Virkar, MA, MS, PMP

United States

Seating is limited.
Data integrity continues to be a hot topic as seen in the regulatory inspections and resulting FDA warning letters. Case studies / select samples of warning letters on data integrity, computer system validation, electronic records, and audit trail will open up discussions for data integrity, data life cycle, and ALCOA principles.

Learning Objective : Describe the current trends of FDA Warning Letters on Data Integrity, with exposure to case studies; Discuss data integrity, and general requirements on data life cycle and ALCOA principle.

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