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Data Integrity • Method Transfers and Validation • Stability Testing

December 4-6, 2019
  • Philadelphia, PA

Join IVT as we embark on our 7th Annual Lab Week journey! Choose between three unique content paths — Laboratory Data Integrity, Analytical Procedures & Methods Validation and Stability Testing — or navigate between all three to customize your Lab Week experience. Designed to maximize your time out of the office, IVT’s Lab Week conference series provides the value of three conferences in one, allowing your entire team to select sessions that best meet your business objectives.

Whether your responsibilities include method validation, method transfers, data integrity or stability, this 3-day laboratory-focused event will provide a comprehensive understanding of global regulatory trends and requirements, including analysis of industry-standards like the May 2018 Bioanyalytical Validation guidance, March 2018 MHRA OOS Guidance and anticipated 2018 FDA Data Integrity guidance (now finalized), as well as “hands-on” training for executing procedures that survive the lifecycle and mitigate data integrity risk, and solutions to top challenges of complying with today’s expanded FDA CDER and CDRH requirements.

FDA KEYNOTE ADDRESS The Regulatory A-Z of Analytical Methods

Sangeeta M. Khurana, PhD
Interdisciplinary Scientist/Investigator (GDUFA),
Office of Pharmaceutical Quality Operations (OPQO) – Division 4,
Office of Medical Products and Tobacco Operations, ORA
U.S. Food and Drug Administration

Topics of Discussion Include:

  • Current regulatory trends, FDA, MHRA, USP and beyond
  • Evaluate and validate the robustness of an analytical method
  • Determine lifecycle, phase appropriate activities
  • Overcome challenges of limits of calculations
  • Implement an effective method transfer strategy
  • Perform an analytical methods comparability study
  • Implement a Quality by Design (QbD) approach
  • Develop, Implement and Maintain a Risk-Based
    Stability Program
  • Break Down Regulatory Guidances for Data Integrity and
    Assess Impact
  • Investigate OOT and OOS in Stability Studies
  • Overcome Stability Challenges of Short-Lived Compounds
  • Explore Combination Therapies Impact on Stability Methods
  • Assess Broadly Packaging and its Role in Stability
  • Discuss Moisture and Oxygen Control in Stability
  • Compare Stability Management in Manufacturing vs
    R&D Environments
  • Achieve Effective Stability Testing Processes in a
    Continuous Manufacturing Environment

Previous Attendee Acclaim:

Great, enthusiastic and convincing speakers!

Supervisor, Abbott

Great opportunity to listen to Method Validation subject matter experts and network with scientists in
similar fields. Highly recommend.

Research Chemist, ECBC

Great conference for analytical chemists!

Associate Chemist II, Upsher-Smith Laboratories

This conference provided with excellent direction and advice that I can use and apply within my own organization

QC Supervisor, Edgewell Personal Care

Great networking opportunity. Great information.
I learned many new things that I had not even
considered as part of my stability program.

Senior Research Associate, Alkermes

IVT consistently assembles the best Subject Matter Experts to address the latest challenges in the stability arena.

Principal Scientist, Genentech

7th Annual Lab Week

Data Integrity • Method Transfers and Validation • Stability Testing

Join IVT as we embark on our 7th Annual Lab Week journey! Choose between three unique content paths — Laboratory Data Integrity, Analytical Procedures & Methods Validation and Stability Testing — or navigate between all three to customize your Lab Week experience. Designed to maximize your time out of the office, IVT’s Lab Week conference series provides the value of three conferences in one, allowing your entire team to select sessions that best meet your business objectives.

Whether your responsibilities include method validation, method transfers, data integrity or stability, this 3-day laboratory-focused event will provide a comprehensive understanding of global regulatory trends and requirements, including analysis of industry-standards like the May 2018 Bioanyalytical Validation guidance, March 2018 MHRA OOS Guidance and anticipated 2018 FDA Data Integrity guidance (now finalized), as well as “hands-on” training for executing procedures that survive the lifecycle and mitigate data integrity risk, and solutions to top challenges of complying with today’s expanded FDA CDER and CDRH requirements.

FDA KEYNOTE ADDRESS The Regulatory A-Z of Analytical Methods

Sangeeta M. Khurana, PhD
Interdisciplinary Scientist/Investigator (GDUFA),
Office of Pharmaceutical Quality Operations (OPQO) – Division 4,
Office of Medical Products and Tobacco Operations, ORA
U.S. Food and Drug Administration

Topics of Discussion Include:

  • Current regulatory trends, FDA, MHRA, USP and beyond
  • Evaluate and validate the robustness of an analytical method
  • Determine lifecycle, phase appropriate activities
  • Overcome challenges of limits of calculations
  • Implement an effective method transfer strategy
  • Perform an analytical methods comparability study
  • Implement a Quality by Design (QbD) approach
  • Develop, Implement and Maintain a Risk-Based
    Stability Program
  • Break Down Regulatory Guidances for Data Integrity and
    Assess Impact
  • Investigate OOT and OOS in Stability Studies
  • Overcome Stability Challenges of Short-Lived Compounds
  • Explore Combination Therapies Impact on Stability Methods
  • Assess Broadly Packaging and its Role in Stability
  • Discuss Moisture and Oxygen Control in Stability
  • Compare Stability Management in Manufacturing vs
    R&D Environments
  • Achieve Effective Stability Testing Processes in a
    Continuous Manufacturing Environment

Previous Attendee Acclaim:

Great, enthusiastic and convincing speakers!

Supervisor, Abbott

Great opportunity to listen to Method Validation subject matter experts and network with scientists in
similar fields. Highly recommend.

Research Chemist, ECBC

Great conference for analytical chemists!

Associate Chemist II, Upsher-Smith Laboratories

This conference provided with excellent direction and advice that I can use and apply within my own organization

QC Supervisor, Edgewell Personal Care

Great networking opportunity. Great information.
I learned many new things that I had not even
considered as part of my stability program.

Senior Research Associate, Alkermes

IVT consistently assembles the best Subject Matter Experts to address the latest challenges in the stability arena.

Principal Scientist, Genentech