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Build Proactive Strategies for the Prevention and Remediation of Data Integrity Non-Compliance

August 16-17, 2017
  • San Diego, CA

Now in its third year, IVT’s Data Integrity Validation continues to provide a wide range of industry perspectives in an unmatched working-group environment. This year’s conference delves deep into the nuances of building and maintaining a compliant data integrity program across company-wide systems.

With more than a year of adjusting to FDA’s Data Integrity and Compliance with cGMP Guidance underway, take this opportunity to reconvene with your peers to benchmark your processes and implement ALCOA+ principals to ensure a data integrity culture throughout your entire organization.

KEY TOPICS INCLUDING:

  • ALCOA+ Principles
  • Design Controls
  • Inspection Preparation
  • Continual Gap Analysis
  • Regulatory Update
  • Laboratory Assessments
  • Risk-Based Approaches
  • Robust CAPA
  • Audit Trail Monitoring

Previous Attendee Acclaim:

If you need ideas to mitigate data integrity issues,
you have to join this conference.

Head, GYPIT Audit Management, Bayer Pharma

Very nice discussions and presenters that help us to
have an industry perspective on new trends.

QA Specialist, Corp. GxPCRs, Amgen

I always take away some useful information.
This conference provided good, useful information
and some practical examples.

Director/Head of QA, CSV, Daiichi Sankyo

Great industry insight into data integrity calculation, audit trail reviews and cloud data storage notes and benefits.

Specialist, Global QA-CSV, Apotex

A fantastic refresher course.

Senior Analyst, Vertex

Tangible knowledge to bring back to work and implement.

CSV Specialist, Par Sterile Products

Beneficial in preparing our company to be
data integrity compliant.

Senior Validation Engineer Computer, Fresenius Kabi

August 16-17, 2017 The Westin San Diego, CA

3rd Annual Data Integrity Validation

Build Proactive Strategies for the Prevention and Remediation of Data Integrity Non-Compliance

Now in its third year, IVT’s Data Integrity Validation continues to provide a wide range of industry perspectives in an unmatched working-group environment. This year’s conference delves deep into the nuances of building and maintaining a compliant data integrity program across company-wide systems.

With more than a year of adjusting to FDA’s Data Integrity and Compliance with cGMP Guidance underway, take this opportunity to reconvene with your peers to benchmark your processes and implement ALCOA+ principals to ensure a data integrity culture throughout your entire organization.

KEY TOPICS INCLUDING:

  • ALCOA+ Principles
  • Design Controls
  • Inspection Preparation
  • Continual Gap Analysis
  • Regulatory Update
  • Laboratory Assessments
  • Risk-Based Approaches
  • Robust CAPA
  • Audit Trail Monitoring

Previous Attendee Acclaim:

If you need ideas to mitigate data integrity issues,
you have to join this conference.

Head, GYPIT Audit Management, Bayer Pharma

Very nice discussions and presenters that help us to
have an industry perspective on new trends.

QA Specialist, Corp. GxPCRs, Amgen

I always take away some useful information.
This conference provided good, useful information
and some practical examples.

Director/Head of QA, CSV, Daiichi Sankyo

Great industry insight into data integrity calculation, audit trail reviews and cloud data storage notes and benefits.

Specialist, Global QA-CSV, Apotex

A fantastic refresher course.

Senior Analyst, Vertex

Tangible knowledge to bring back to work and implement.

CSV Specialist, Par Sterile Products

Beneficial in preparing our company to be
data integrity compliant.

Senior Validation Engineer Computer, Fresenius Kabi

August 16-17, 2017 The Westin San Diego, CA