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Tuesday, June 26 • 9:15am - 9:45am
#219: FDA Warning Letters on Data Integrity

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Component Type: Session
Level: Basic
CE: IACET 0.50

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 Objectives

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.

Chair

Anu Virkar, MA, MS


Speakers
avatar for Anu Virkar

Anu Virkar

Vice President, Quality and Compliance, eClinical, Merge eClinical, An IBM Watson Health
Anu Virkar, MS, MA, PMP is the VP of Q&C. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and Med device industry for over 15 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She... Read More →


Tuesday June 26, 2018 9:15am - 9:45am
Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA