Agenda: On February 25, 2002, the subcommittee will:
(1) Identify and define technology and regulatory uncertainties/hurdles, possible solutions, and strategies for the successful implementation of process analytical technologies (PATs) in pharmaceutical development and manufacturing;
(2) discuss general principles for regulatory application of PATs including principles of method validation, specifications, use and validation of chemometric tools, and feasibility of parametric release concept; and
(3) discuss the need for a general FDA guidance to facilitate the implementation of PATs.
On February 26, 2002, the subcommittee will discuss strategies to explore issues in the following four focus areas:
(1) Product and process development,
(2) process and analytical validation,
(3) chemometrics, and
(4) process analytical technologies, applications and benefits.