Food and Drug Administration

Process Analytical Technologies (PAT) Subcommittee of the
Advisory Committee for Pharmaceutical Science

February 25, 2002


Overview and Objectives, Ajaz S Hussain, PhD, Office of Pharmaceutical Science, FDA   ppt   htm

Applications and Benefits of PAT, Steve Hammond, Global Manufacturing Services   ppt   htm

Pharma Manufacturing: Why there is a need to improve.  The role of PAT, Dr Doug Dean, Frances Bruttin, PWC Consulting   ppt   htm

Process Analytical Technology: An Industry Perspective, John G Shabushnig, PhD, Pharmacia Corporation   ppt   htm

Process Analytical Technologies Subcommittee Product Process Development: An Industry Perspective, David Rudd PhD, GlaxoSmithKline Research and Development   ppt   htm

Perspective on Process and Analytical Validation, Robert S Chisholm, AstraZeneca   ppt   htm

Process and Method Validation, Leon Lachman, PhD, Lachman Consultant Services Inc   ppt   htm

Chemometrics and PAT: An Opinion on Current Status and Recommendations for the Future, Jerry Workman Jr, Kimberly-Clark Corp   ppt   htm

Perspectives in Chemometrics, Experience Form GlaxoSmithKline   ppt   htm

Open Public Hearing

Extended Range NIR Wavelength Standard, Gabor J Kemeny PhD, Kemtek Analytical Inc    ppt  htm

How to Test for Linearity, Howard Mark, Mark Electronics   pdf   htm   doc