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, co-sponsored by European Compliance Academy (ECA), 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.
Through presentations, case studies and open discussions, participants will learn more about the lifecycle management of analytical procedures and participate in a forum for discussing USP’s new general chapter and Stimuli articles related to this topic. Participants will 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.
- Learn about the new calculation tool kit – General Chapter <1210> – and how it facilitates and simplifies the statistical calculations required for validation
- Understand how to establish an analytical target profile and analytical control strategy
- Discuss the harmonization of nomenclature for development, qualification and verification of analytical procedures as part of a lifecycle concept
- Engage with USP’s Validation and Verification Expert Panel on USP’s new general chapter
Who Should Participate?
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
For further information, please click here.
Fees (per delegate plus VAT)
Fees per person
EU GMP Inspectorates
The conference fee is payable in advance after receipt of invoice and includes conference documentation, social event & dinner, lunch on both days, and all refreshments. VAT is reclaimable.
Invitation Letters for Visas
USP cannot provide an invitation letter to potential workshop attendees. Not sure if you need a Visa? Refer to the Ministry of Foreign Affairs of the Czech Republic website on citizens required to have a Visa for entry. General Visa information can also be found on the Ministry’s site.
To register, please click here.
For specific registration questions, please contact Oliver Schmidt at firstname.lastname@example.org.
Hotel and Meeting Location
The workshop will take place entirely at:
Corinthia Hotel Prague
Prague 4, 140 69
Local Area Information
If you require hotel accommodations, please note that you will be sent instructions on reserving a room inside the event block after registering.
Prague is served by the Vaclav Havel Airport Prague (PRG).
Ground transportation options from the airport to the Corinthia Hotel can be found on the Vaclav Havel Airport Prague website. You may also email email@example.com after making your hotel reservation at the Corinthia Hotel and ask the concierge to arrange an airport pick-up on your behalf to be billed to your room.