Goals and Anticipated Outcomes
The workshop will explore the lifecycle concept for analytical procedures. These concepts have been described in the five USP papers listed below*.
The workshop will consist of case studies that illustrate the concepts of the lifecycle approach. This will include hands-on applications such as drafting an ATP, developing a control strategy, qualifying a method, and monitoring method performance during routine use.
Attendees will gain a better understanding of how Lifecycle principles can be applied to analytical procedures and are invited to provide feedback about the USP proposal for adopting a General Chapter on the lifecycle approach to analytical procedures.
- Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification [PF 39(5)]
- Fitness for Use: Decision Rules and Target Measurement Uncertainty [PF 42(2)]
- Analytical target profile (ATP): Structure and application throughout the analytical lifecycle [PF 42(5)]
- Analytical control strategy [PF 42(5)]
- Proposed New USP General Chapter: The Analytical Procedure Lifecycle 〈1220〉 [PF 43(1)]
Vendors are invited to participate in the workshop to demonstrate any software or equipment that can be used in analytical method development, validation and multivariate data analysis following aQbD concepts. Table tops will be open during various networking breaks for live demonstrations. Please see the Exhibitor Signup Information form for more information.
USP would like to thank the following vendor partners who will be exhibiting at the event:
Who Should Attend
- Analytical chemists
- Quality control analysts
- Quality assurance associates, managers
- Research and development scientists, statisticians, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract laboratories
- Federal regulatory reviewers
- Project managers
Workshop Participating Organizations
- Mark Argentine, Eli Lilly & Co
- Kimber Barnett, USP Validation and Verification Expert Panel
- Phil Borman, GSK
- Joachim Ermer, USP Validation and Verification Expert Panel
- John Harrahy, Amgen
- Brent Harrington, Pfizer
- Gary Kemp, British Pharmacopeia
- Elisabeth Kovacs, USP Validation and Verification Expert Panel
- Rosario LoBrutto, USP Validation and Verification Expert Panel
- Greg Martin, USP Validation and Verification Expert Panel
- Pauline McGregor, USP Validation and Verification Expert Panel
- Phil Nethercote, USP Validation and Verification Expert Panel
- Horacio Pappa, U.S. Pharmacopeia
- Antonio Ramos, Hovione
- Ramakrishna Velicheti, U.S. Food & Drug Administration
- Steven Walfish, U.S. Pharmacopeia
Workshop Registration Information
Advance registration will be available through Thursday, September 20, 2018. After that date, registration will be available on site at the USP Meetings Center.
Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks and lunches. Registration fees for this workshop have been set as follows:
|Participant Type|| Regular Fee Per Person
(1-2 individuals from the same organization)
(3 or more individuals from the same organization; all must register at the same time to receive the discount)
Cancellation and Substitution Policy
Cancellation must be received on or before September 3, 2018 via email to firstname.lastname@example.org. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to email@example.com.
Invitation Letters for Visas
USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.
Please contact firstname.lastname@example.org or +1 301-816-8130.
Hotel & Travel Information
Please note that the headquarter hotel for this workshop is the Cambria Rockville. Daily Shuttle service will be provided between USP and the Cambria only. The rate is $139.00 per night plus tax when you book using the link below:
For information on additional local hotels, please click here. Please note that transportation will not be offered from any hotel except the Cambria.