Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Best practices and strategic approach for evaluating computer systems

  • 15-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

APPLYING COMPUTER SYSTEM VALIDATION TO MOBILE APPLICATIONS

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Computer system validation can be applied to mobile applications

  • 12-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Best Practices for Preparing for an FDA Computer System Validation Audit

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Current trends in compliance and enforcement that can help in preparation for an FDA inspection or audit

  • 16-September-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
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