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Analytical Procedures and Methods Validation

: 22 Jun 2020 - 24 Jun 2020

: San Diego, United States

Sector: Pharmaceutical

Type: Conference, Meeting, Training

It has never been more important to stay up-to-speed with current regulatory thinking. Between the FDA's interest in releasing guidance’s the last few years on analytical procedures & methods validation, bioanalytical methods validation and a flurry of global regulations on data integrity, it is critical for you and your company to receive the training you need and avoid regulatory action. FDA, ICH, and USP all recognise analytical development and validation as the top priority in the drug development process and each has respective guidance, albeit interpretation is left to industry. Not only does this event take a deep dive into how companies comply with regulations but it also showcases how leading companies develop methods, validate procedures and generate data and information that lead to critical business decisions. This conference takes participants on a best-practice journey through the development, validation, and transfer of analytical methods.


Choose from over 20 tutorials addressing today’s top analytical challenges.


Analytical Procedures and Methods Validation Highlights Include:

  • Adopt a systematic approach for method robustness with effective design of experiments (DoE)
  • Evaluate performance through analysing samples from in-process through the finished product
  • Define and develop the content and scope of analytical procedures program
  • Conduct suitability tests and establish acceptance criteria for system functionality excellence
  • Develop a roadmap for analytical methods validation
  • Evaluate characteristics through statistical analysis of validation data
  • Development and validation of a stability-indicating analytical method
  • Learn how to perform risk-based evaluations
  • Post-marketing change control procedures for approved NDA, ANDA and BLA
  • Handle the FDA laboratory methods verification process
  • Effectively manage transfer studies and protocols


Maximize your training! This event is co-located with Laboratory Data Integrity Compliance Congress


San Diego
United States


KENX Knowledge Exchange Network
Phone: 858 649 3251
Email: info@kenx.org
Visit: https://www.kenx.org/

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