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Proactive GxP Strategies • Audit Trail Review • Laboratory Assessments • Robust CAPA • Gap Analysis

December 4-6, 2017
  • Philadelphia, PA

As data integrity continues to increase in FDA regulators’ focus within analytical laboratories, now more than ever it is critical for laboratory and validation professionals to convene and develop a toolbox for building compliant data integrity programs. Break down data integrity models as outlined in the 2016 Data Integrity and Compliance with CGMP Draft Guidance to ensure that data is both accurate and thorough. Join IVT this December at Laboratory Data Integrity to benchmark against industry peers and ensure quality control in the laboratory environments, avoiding FDA warning letters and fines to prevent loss of time and resources and build a strong reputation for your organization.

NEW THIS YEAR!

Auditor Perspective

Outside Optics — From Upstream Development to Operations

Lina Patel, PhD
Director, Quality Operations Bio-Analytical Laboratory
Merck Manufacturing Division

Office Hours!

Gain insights on your individual laboratory and method validation challenges by meeting one-on-one with Lab Week speaking faculty.

Engage in 15 Interactive Courses and
Critical Discussions, Including:

  • Data Integrity Update —
    Implementation of Regulatory Guidances in Analytical Methods,
    Stability Testing and Lifecycle Laboratory Management
  • ELN and LIMS Case Study — Benefits and Challenges of
    Managing Sample Workflows in the Laboratory
  • Integrating a Data Integrity Compliance Plan into
    Your Organization’s DNA
  • Audit Trail Reviews for Data Integrity
  • Steps for Implementing a Robust CAPA Program for
    Data Integrity Non-Compliance
  • Improve User Training to Minimize Risk of User Work-Arounds
  • Overcome the Challenges of Paperless Implementations
  • Effective Training Methods for Data Integrity
  • Mitigating Data Integrity Risk in Analytical Methods and
    Stability Testing
  • Lifecycle Management in the Laboratory

Laboratory Data Integrity

Proactive GxP Strategies • Audit Trail Review • Laboratory Assessments • Robust CAPA • Gap Analysis

As data integrity continues to increase in FDA regulators’ focus within analytical laboratories, now more than ever it is critical for laboratory and validation professionals to convene and develop a toolbox for building compliant data integrity programs. Break down data integrity models as outlined in the 2016 Data Integrity and Compliance with CGMP Draft Guidance to ensure that data is both accurate and thorough. Join IVT this December at Laboratory Data Integrity to benchmark against industry peers and ensure quality control in the laboratory environments, avoiding FDA warning letters and fines to prevent loss of time and resources and build a strong reputation for your organization.

NEW THIS YEAR!

Auditor Perspective

Outside Optics — From Upstream Development to Operations

Lina Patel, PhD
Director, Quality Operations Bio-Analytical Laboratory
Merck Manufacturing Division

Office Hours!

Gain insights on your individual laboratory and method validation challenges by meeting one-on-one with Lab Week speaking faculty.

Engage in 15 Interactive Courses and
Critical Discussions, Including:

  • Data Integrity Update —
    Implementation of Regulatory Guidances in Analytical Methods,
    Stability Testing and Lifecycle Laboratory Management
  • ELN and LIMS Case Study — Benefits and Challenges of
    Managing Sample Workflows in the Laboratory
  • Integrating a Data Integrity Compliance Plan into
    Your Organization’s DNA
  • Audit Trail Reviews for Data Integrity
  • Steps for Implementing a Robust CAPA Program for
    Data Integrity Non-Compliance
  • Improve User Training to Minimize Risk of User Work-Arounds
  • Overcome the Challenges of Paperless Implementations
  • Effective Training Methods for Data Integrity
  • Mitigating Data Integrity Risk in Analytical Methods and
    Stability Testing
  • Lifecycle Management in the Laboratory