Valimed

[paige]

Here is the Town Meeting that (I guess) we must have been at...


http://www.fda.gov/OHRMS/DOCKETS/98fr/020602e.htm



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.


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Here is the overview of the Feb meeting

http://www.fda.gov/ohrms/dockets/ac/cder02.htm#PharmaceuticalScience


Here is one of the Presenters that we mentioned in our response back to ASD...AstraZeneca...


http://www.fda.gov/ohrms/dockets/ac/02/slides/3841s1_06_chisholm.ppt#264,5,SolidDosageFacility


....If you hang on long enough the NIR will show up at all of the green boxes or stages of development except the last one where they coat the pill...


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Oh yeah...here is the real "key"....Just thought you may want to see for yourself..scroll down..



Working Group 1...

take a look Mr. Curtiss was there... big as you Please....

http://www.fda.gov/ohrms/dockets/ac/02/roster/3841r1_02_workinggroup1.htm