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Develop and Implement Procedures that Survive the Lifecycle

December 4-6, 2018
  • San Diego, CA

New Final Guidance Released!

On May 22nd FDA released a final guidance on Bioanalytical Method Validation. This guidance serves to inform the development of methods used to ensure the effectiveness for safety and effectiveness of drugs and biologic products. As stated in the documents, “Validating the analytical method ensures that the data are reliable by addressing certain key questions, including:

  • Does the method measure the intended analyte?
  • What is the variability associated with these measurements?
  • What is the range in measurements that provide reliable data?
  • How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?”

Join us this December to discuss!

IVT’s 15th ANNUAL ANALTYICAL PROCEDURES AND METHODS VALIDATION RETURNS TO SAN DIEGO!

The laboratory landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data. From FDA’s final guidance on analytical procedures to USP chapter updates to FDA and MHRA’s determination to enforce action on data integrity, the demand for attention to compliance detail has never been greater.

Whether your responsibilities include method development, method validation, method verification or method transfer, this 3-day laboratory-focused event will provide a comprehensive understanding of global regulatory trends and requirements, “hands-on” training for executing procedures that survive the lifecycle, and solutions to top challenges of complying with today’s expanded FDA CDER requirements.

Join your colleagues at IVT’s Analytical Procedures & Methods Validation this December and go beyond just theory to gain practical examples, tools, SOPs, templates and knowledge to ensure regulatory excellence in your analytical lab.

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

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

IVT Lab Week’s Analytical Procedures & Methods Validation

Develop and Implement Procedures that Survive the Lifecycle

New Final Guidance Released!

On May 22nd FDA released a final guidance on Bioanalytical Method Validation. This guidance serves to inform the development of methods used to ensure the effectiveness for safety and effectiveness of drugs and biologic products. As stated in the documents, “Validating the analytical method ensures that the data are reliable by addressing certain key questions, including:

  • Does the method measure the intended analyte?
  • What is the variability associated with these measurements?
  • What is the range in measurements that provide reliable data?
  • How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?”

Join us this December to discuss!

IVT’s 15th ANNUAL ANALTYICAL PROCEDURES AND METHODS VALIDATION RETURNS TO SAN DIEGO!

The laboratory landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data. From FDA’s final guidance on analytical procedures to USP chapter updates to FDA and MHRA’s determination to enforce action on data integrity, the demand for attention to compliance detail has never been greater.

Whether your responsibilities include method development, method validation, method verification or method transfer, this 3-day laboratory-focused event will provide a comprehensive understanding of global regulatory trends and requirements, “hands-on” training for executing procedures that survive the lifecycle, and solutions to top challenges of complying with today’s expanded FDA CDER requirements.

Join your colleagues at IVT’s Analytical Procedures & Methods Validation this December and go beyond just theory to gain practical examples, tools, SOPs, templates and knowledge to ensure regulatory excellence in your analytical lab.

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

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