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Hands-On Training for Small Molecules, Biologics and Medical Device to Harmonize Global Systems and Conduct Effective Analytical Method Transfers

June 19-21, 2018
  • London, United Kingdom

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 next month to discuss!

As the laboratory landscape continues to face an influx of regulations surrounding the reliability, consistency and accuracy of analytical methods and data, now more than ever it is critical for the global biopharmaceutical industry to adhere to new regulatory expectations.

Whether your responsibilities include method development, method validation, method verification or method transfer, IVT’s 3-day event — Analytical Procedures & Methods Validation — will provide a comprehensive understanding of global regulatory trends and requirements, “hands-on” training for executing procedures that survive the lifecycle, and solutions to unique challenges within the laboratory environment.

Join your colleague this June to ensure your organisation is generating reproducible and reliable results by breaking down ICH, WHO and FDA guidances, implementing data integrity best practices, navigating statistics and reporting and implementing a lifecycle approach to analytical methods and procedures.

Go Beyond Just Theory and Gain Practical, Customised Solutions For:

  • Evaluating and Validate the Robustness of an Analytical Method
  • Determining Lifecycle, Phase Appropriate Activities
  • Mitigating Data Integrity Risk in Analytical Methods —
    Break down MHRA, WHO, FDA, PIC/s and EMA guidance
  • Implementing and Optimising an Effective Method Transfer Strategy
  • Exploring FDA Guidance on Analytical Methods
  • Using Design of Experiments to Speed Up Method Development
    and Validation
  • Conducting a process gap analysis
  • USP proposed chapter on the Analytical Procedure Lifecycle
  • USP proposed revision to USP on Analytical Instrument Qualification
  • Establish Acceptance Criteria for Analytical Methods

Download the Lab Week Agenda at a Glance

Previous Attendee Acclaim:

Great discussion of analytical method validation with
practical examples of how to approach method variation.

QC Specialist, Gilead Sciences

Excellent course material and well delivered.

Analytical Chemist, Avara

Very knowledgeable speakers, and they were very approachable. A lot of useful information and good references.

EMEA Applications Specialist, GE Analytical Instruments

Excellent speakers and organisation of conference events.

QC Analyst, UCB, Inc.