USP and ECA Academy Co-Host New Conference on Lifecycle Approach to Analytical Procedures

[Washington/Heidelberg 5th April 2016] — The United States Pharmacopeial Convention (USP) and the ECA Academy announce their cooperation in organising a joint conference entitled, “Lifecycle Approach to Analytical Procedures”. The conference will take place in Prague, Czech Republic, on 8th and 9th November 2016 at the Corinthia Hotel.

The validation of analytical procedures is a critical part of any process for ensuring drug quality. Since 2014, USP’s Validation and Verification Expert Panel has been considering how the modern concept of lifecycle model process validation can be applied to analytical procedures. This conference will address how USP’s proposed vision for the development of a new general chapter aligns with the principles of US FDA and EU Annex 15 guidance on process validation and analytical quality by design. This covers design, development, qualification, transfer and verification.

Conference presentations, case studies and open discussions will help participants learn more about the lifecycle management of analytical procedures and provide a forum for discussing USP’s new general chapter and Stimuli articles related to this topic. Participants will thus have the opportunity to give feedback and ask questions directly to USP’s Expert Panel Members on how to move forward with the transition to and implementation of the lifecycle approach.

The meeting will also address topics such as:

  • a new calculation tool kit – General Chapter <1210> – to facilitate and simplify the statistical calculations required for validation
  • establishing an analytical target profile as well as an analytical control strategy
  • harmonization of nomenclature for development, qualification and verification of analytical procedures as part of a lifecycle concept.

The USP and the ECA Academy wish to actively involve analytical chemists, QC analysts, quality assurance associates & managers, R&D scientists, statisticians & managers as well as manufacturing scientists and managers, regulatory affairs specialists and contract laboratories in this critical area for analytical science.

To learn more about the conference please visit www.validation-analytical.com.

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