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Online training: Analytical strategy and method development

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2022/11/18 9 AM CET (UTC+1)

Scope

New ICH and pharmacopoeia regulations are creating the need for a risk-based approach to analytical method development and validation. This is the result of efforts to implement QbD (Quality by Design) in the pharmaceutical industry. Until now, QbD was applied to the manufacturing process, but now its application is also expanded to analytics and control strategy.
The online training “Analytical strategy and method development” will allow participants to implement the new regulations for building analytical strategy as well as the development of analytical methods.

The online course takes place on clickmeeting platform and takes seven hours.

strategy

For whom?

Analytical specialists working in R&D or MSAT departments who are responsible for method development, validation and transfer. Managers and Subject Matter Experts who are responsible for development of control strategy, studies planning and registration policy.

Topics

  • Regulatory environment
  • Overview of the recent regulations
  • Introduction to control strategy
  • Risk assessment of quality attributes
  • Analytical Methods Lifecycle
  • Analytical Target Profile
  • Analytical method development strategy
  • Analytical method risk assessment
  • Approaches for method development
  • Method control strategy
  • On going monitoring

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