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Event Details


Keeping your analytical method in compliance with Good Manufacturing Practices (GMPs)

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Who should attend?

This course will benefit analytical chemists, staff scientists, investigators in quality control lab, R&D, production, manufacturing, contract labs, quality assurance, regulatory affairs, laboratory auditors, lab inspectors, data reviewers, lab investigators. This course is not intended for microbiologists.


Analytical laboratories play important roles in the pharmaceutical industry. The generation of data under conditions that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; therefore, keeping the analytical method in compliance with validation requirements and product changes is a challenge for analytical scientists.

This course will review the current regulations, provide updates from FDA, ICH, USP, and WHO, and different aspects of validation throughout development phases to establish critical acceptance criteria. It will also discuss different strategies to transfer an analytical method systematically. Participants should expect to share their experiences and discuss Best Practices to keep method stay in compliance with Good Manufacturing Practices (GMPs).

A One Day Interactive Presentation, Case Studies and Exercises on:

Regulatory expectations of Method Validation

  • Current review of critical GMP issues in analytical labs
  • Common 483s observations and warning letters
  • Review ICH Q2 A&B guidelines
  • USP <1225> and <1226> requirements

Development of stability indicating test methods

  • Discuss validation characteristics
  • Stress testing and forced degradation studies
  • Key issues with Q3 A/B for impurities monitoring
  • Validation process and method Lifecycle

Documentation of Method Validation

  • Structure of a validation protocol
  • Establish documentation principles
  • Establish acceptance criteria
  • Content of the Analytical Method

Method Transfer Process

  • Purpose of Analytical Method Transfer
  • USP <1224> and transfer strategies
  • Phases of Method Transfer Process
  • Understand the dynamic relationship of validation, verification and transfer

Interactive discussions on Method Transfer issues


Early Bird: Till July 31, 2018 $484 CAD + HST Regular Price: August 1, 2018 to October 02, 2018 $584 CAD + HST Academia / Government $294 CAD + HST



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